Resource Library for Medical Device Professionals

268 total results. Use the filters to narrow down the results.

This chart illustrates the steps in the Australia TGA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about the Australia medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This video series about the Australia medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 16 minutes

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Thinking about entering the Australian market for the first time? Understanding the TGA's regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.view all

記事 | 6 pages

Interested in selling your medical device or IVD in Australia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A brief look at Australia's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Australia and major medical device regulations.view all

市場調査 | 1 page

A comprehensive list of medical device regulations in Australia with links to the original documents.view all

規制 | Downloadable PDFs

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.view all

記事 | 8 pages

This chart illustrates the steps in the Brazil ANVISA IVD approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about the Brazil medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Thinking about selling your medical device in Brazil? This Brazillian market is complex but the sales potential is worth the effort.view all

記事 | 9 pages

Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but very complex. It's important to understand the process upfront to avoid delays down the road.view all

記事 | 11 pages

This video series about the Brazil medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 14 min

This chart illustrates the steps in the Brazil ANVISA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

In this white paper, learn about recent changes to the regulatory process for IVDs in Brazil.view all

記事 | 7 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Interested in selling your medical device or IVD in Brazil? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Thinking about entering the Brazilian market for the first time? Understanding the ANVISA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.view all

記事 | 8 pages

Learn about the regulatory structure in Brazil and major medical device regulations.view all

市場調査 | 1 page

A brief look at Brazil's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Canada and major medical device regulations.view all

市場調査 | 1 web page

This chart illustrates the steps in the Health Canada IVD approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This chart illustrates the steps in the Health Canada medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This white paper includes a detailed comparison of Health Canada's Medical Device License application and a US FDA 510(k). view all

記事 | 17 pages

This video about the Canada medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This short video covers the 6 biggest changes in the new ISO 13485:2016.view all

ビデオ | 5 minutes

An in-depth look at Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL).view all

記事 | 6 pages

Interested in selling your medical device or IVD in Canada? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Thinking about entering the Canadian market for the first time? Understanding the Health Canada regulatory requirements can be confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.view all

記事 | 8 pages

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Health Canada will only accept quality system certificates which have been issued by CMDCAS recognized registrars.view all

市場調査 | 1 web page

A brief look at Canada's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Learn about the regulatory structure in China and major medical device regulations.view all

市場調査 | 1 web page

This chart illustrates the steps in the China CFDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Thinking about entering the Chinese market for the first time? Understanding the CFDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

Interested in selling your medical device or IVD in China? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A brief look at China's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This white paper discusses how to register your medical device with the CFDA in China.view all

記事 | 8 pages

This chart illustrates the steps in the Colombia INVIMA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about the Colombia medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Interested in selling your medical device or IVD in Colombia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

INVIMA is in charge of providing medical approval for the import and export of products, including medical devices. The regulatory authority was created in 1992 under the Ministry of Health of Colombia. Learn more about the agency.view all

 

This chart illustrates the steps in Costa Rica's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Costa Rica? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A comprehensive list of medical device regulations in Costa Rica with links to the original documents.view all

規制 | PDFs

Learn about the regulatory structure in Costa Rica and major medical device regulations.view all

市場調査 | 1 page

Interested in selling your medical device or IVD in Egypt? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A comprehensive list of medical device regulations in Egypt with links to the original documents.view all

規制 | PDFs

ISO 13485:2016 provides an international QMS standard and introduces notable changes, particularly in the area of risk management.view all

記事 | 16 pages

Europe's new Medical Device Regulation 2017/745 (MDR) will bring substantial changes to the medical device industry. How will this affect your company?view all

記事 | 14 pages

Europe's new IVDR 2017/746 will bring significant regulatory changes for IVD manufacturers selling in Europe.view all

記事 | 16 pages

The transition deadline for EU MDR 2017/745 seems distant, but there are a lot of factors to consider when coordinating and planning the transition strategy.view all

記事 | 10 pages

This chart illustrates steps to CE Marking in Europe's Medical Devices Regulation (MDR 2017/745) approval process.view all

チャート | 2 pages

This chart illustrates the steps in Europe's IVD approval process and includes a timeline of expected approval.view all

チャート | 2 pages

In this recorded webinar we will tell you how to deal with the issue of transitioning to another Notified Body and/or how to evaluate your options in establishing a new relationship.watch now

Webinar | 1 hour

In this webinar, we outline the most important MDR changes you need to know.watch now

Webinar | 1 hour

In this recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body.watch now

Webinar | 1 hour

This chart illustrates the steps in Europe's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This white paper provides an overview of new risk requirements and considerations for devices companies under the new standard.view all

記事 | 12 pages

Take a deep dive into the key elements of an EU Technical File, including preparation, formatting, and common elements.view all

記事 | 8 pages

In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.view all

記事 | 5 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

This short video covers the 6 biggest changes in the new ISO 13485:2016.view all

ビデオ | 5 minutes

A comprehensive list of medical device regulations in Europe with links to the original documents.view all

規制 | Downloadable PDFs

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.view all

記事 | 6 pages

This video about provides an overview of the regulatory framework and registration process basics for devices.view all

ビデオ | 4 minutes

Europe's new Medical Devices Regulation (MDR) adds to the complexity of complying with specific PMS and post-market clinical follow-up (PMCF) requirements. In this free webinar, we discuss new European PMS and PMCF requirements.watch now

Webinar | 1 hour live webinar

This white paper explores risk management procedures and protocols required to comply with ISO 14971.view all

記事 | 9 pages

In this video, learn more about the background of EN ISO 13485, and the steps you can take to obtain ISO 13485 certification in Europe.view all

ビデオ | 29 minutes

Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. IVDR 2017/745 will be an entirely new classification scheme for IVDS, and places far more emphasis on clinical data and risk management watch now

Webinar | 1 hour

This free recorded webinar is about risk management for medical device companies according to EN ISO 14971:2012.watch now

Webinar | One hour

Your conformity assessment route has implications for your business you might not expect. How do you know which route is best for you?view all

記事 | 6 pages

This video explores CERs, including what they are, why you need one, the research process, and contents and formatting.view all

ビデオ | 4 minutes

How do you classify a product that fits the definition of two or more product types? This paper explains borderline classification in the EU.view all

記事 | 5 pages

A brief look at Sweden's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

In this video, learn about medical device labeling symbols, their meanings, and how they communicate important product information.view all

ビデオ | 11 min

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.view all

記事 | 16 pages

Learn about the standards, requirements, and benefits of medical device labeling and symbols. Includes a list of common symbols and meanings.view all

記事 | 7 pages

Vigilance reporting is confusing for many manufacturers in Europe but it is critical to comply with vigilance requirements. In this whitepaper, we'll answer your biggest questions about vigilance reporting.view all

記事 | 7 pages

How to avoid errors in communication, planning, conduct, evaluation, or reporting of clinical studies that could delay your market access in Europe.view all

記事 | 10 pages

This white paper discusses key points of the Notified Body search, including how to find a new Notified Body well-suited to your company.view all

記事 | 5 pages

A brief look at Switzerland's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

This white paper discusses PMCF study requirements in Europe and relevant changes under the new MDR.view all

記事 | 7 pages

A brief look at Belgium's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

A brief look at the United Kingdom's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

A brief look at the Czech Republic's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

CEマーキングを必要とするヨーロッパ諸国view all

市場調査 | 1 web page

CE Marking is required to sell your medical device in Europe. Get an overview of the process, requirements, regulations, and more.view all

記事 | 8 pages

A brief look at France's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Learn about the regulatory structure in France and major medical device regulations.view all

市場調査 | 1 page

A brief look at Germany's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

This white paper discusses the European clinical investigation requirements and how to know when you're ready for this important step.view all

記事 | 5 pages

Learn about the regulatory structure in Italy and major medical device regulations.view all

市場調査 | 1 page

In this white paper, we discuss audit and assessment duties for Notified Bodies in Europe, including performing unannounced audits.view all

記事 | 9 pages

ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.view all

記事 | 12 pages

A brief look at Ireland's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

The clinical evaluation report (CER) is a key component of Technical File and the CE Marking process so it's important to get it right.view all

記事 | 5 pages

Learn about the regulatory structure in Spain and major medical device regulations.view all

市場調査 | 1 page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A brief look at Italy's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Learn about the regulatory structure in The Netherlands and major medical device regulations.view all

市場調査 | 1 page

This video series about the European medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 21 minutes

A brief look at The Netherlands' medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

A brief look at Poland's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

A brief look at Europe's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 page

A brief look at Spain's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Interested in selling your medical device or IVD in Europe? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about Clinical Evaluation Reports (CERs) in this informative page from Emergoview all

 

Learn about the regulatory structure in Germany and major medical device regulations.view all

市場調査 | 1 page

This chart illustrates the steps in the Hong Kong MDCO medical device approval process and includes a timeline of expected approval.view all

チャート | 1 page

Interested in selling your medical device or IVD in Hong Kong? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Interested in selling your medical device or IVD in India? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A brief look at India's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 page

A comprehensive list of medical device regulations in India with links to the original documents.view all

規制 | Downloadable PDFs

Learn about the regulatory structure in India and major medical device regulations.view all

市場調査 |

Interested in selling your medical device or IVD in Israel? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

This short video covers how to register your medical device with AMAR in Israel.view all

ビデオ | 6 minutes

In this white paper, we discuss quality system assessment under Japan's new regulation, the Pharmaceutical and Medical Device Act.view all

記事 | 8 pages

This video series about Japan's medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 17 minutes

In this white paper, we discuss how to register a medical device for sale in Japan as a foreign company and requirements to be aware of.view all

記事 | 6 pages

This video about Japan's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This chart illustrates the steps in Japan's PMDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Interested in selling your medical device or IVD in Japan? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the most complex aspects of the Japanese medical device registration process from EMERGO's VP of Business Development.watch now

Webinar | 47 minutes

Thinking about entering the Japanese market for the first time? Understanding the PMDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

Determining the Japanese clinical data requirements for your device can be challenging. This paper explains PMDA clinical requirements.view all

記事 | 8 pages

A brief look at Japan's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

A comprehensive list of medical device regulations in Japan with links to the original documents.view all

規制 | Downloadable PDFs

Learn about the regulatory structure in Japan and major medical device regulations.view all

市場調査 | 1 page

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.view all

記事 | 8 pages

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Learn about Malaysia's medical device and IVD regulations and registration requirements in this white paper. view all

記事 | 6 pages

This chart illustrates the steps in Malaysia's MDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Malaysia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A comprehensive list of medical device regulations in Malaysia with links to the original documents.view all

規制 | Downloadable PDFs

Learn about the regulatory structure in Malaysia and major medical device regulations.view all

市場調査 | 1 page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Mexico and major medical device regulations.view all

市場調査 | 1 web page

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This video series about Mexico's medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 16 minutes

This chart illustrates the steps in Mexico's medical device and IVD approval process and includes a timeline of expected approval.view all

チャート | 2 page chart

This white paper discusses the advantages and disadvantages to consider when choosinig a medical device registration route in Mexico.view all

記事 | 10 pages

Mexico's importation process is challenging. This white paper explores how to successfully import medical devices to Mexico.view all

記事 | 7 pages

Interested in selling your medical device or IVD in Mexico? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Thinking about entering the Mexican market for the first time? Understanding the COFEPRIS regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

A brief look at Mexico's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.view all

記事 | 6 pages

Interested in selling your medical device or IVD in New Zealand? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in New Zealand and major medical device regulations.view all

市場調査 | 1 page

Interested in selling your medical device in Peru? Emergo offers several services for companies looking to enter this market.view all

Service Overview | Varies

A comprehensive list of medical device regulations in Peru with links to the original documents.view all

規制 | Downloadable PDFs

This chart illustrates the steps in Russia's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Russia is a promising market for medical devices, but the regulatory process can be challenging. Learn what's involved in this short video.view all

ビデオ | 6 minutes

This white paper discusses the regulatory landscape in Russia, challenges manufacturers might face, and changes expected to be introduced.view all

記事 | 7 pages

Interested in selling your medical device or IVD in Russia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A brief look at Russia's medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This video about Saudi Arabia's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This chart illustrates the steps in Saudi Arabia's SFDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

An overview of the medical device regulatory system in Saudi Arabia, including the history, framework, and registration process.view all

記事 | 10 pages

Interested in selling your medical device or IVD in Saudi Arabia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in Saudi Arabia and major medical device regulations.view all

市場調査 | 1 page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This chart illustrates the steps in Singapore's HSA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Learn about medical device regulations in Singapore, including classification, registration routes, submission requirements, and more.view all

記事 | 7 pages

This video about Singapore's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Thinking about entering the Singapore market for the first time? Understanding the HSA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

Interested in selling your medical device or IVD in Singapore? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in Singapore and major medical device regulations.view all

市場調査 | 1 page

Interested in selling your medical device or IVD in South Africa? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in South Africa and major medical device regulations.view all

市場調査 | 1 page

South Korea's complex regulatory requirements can be difficult to navigate, especially for regulatory professionals not fluent in Korean. In this free webinar, we will take a closer look at medical device registration requirements in South Korea.watch now

Webinar | 1 hour recorded webinar

An overview of the medical device regulations in South Korea, including the QMS compliance, classification, and submission requirements.view all

記事 | 16 pages

This chart illustrates the steps in South Korea's MFDS medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video series about South Korea's medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 15 minutes

This four minute video provides an overview of South Korea's medical device registration process.view all

ビデオ | 4 minutes

Interested in selling your medical device or IVD in South Korea? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Thinking about entering the South Korean market for the first time? Understanding the MFDS regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

市場調査 | 1 page

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

A comprehensive list of medical device regulations in South Korea with links to the original documents.view all

規制 | Downloadable PDFs

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This video about Taiwan's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This white paper discusses how to register your medical device with the TFDA in Taiwan.view all

記事 | 6 pages

This chart illustrates the steps in Taiwan's TFDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Taiwan? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

This video about the Taiwan medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 10 minutes

A comprehensive list of medical device regulations in Taiwan with links to the original documents.view all

規制 | Downloadable PDFs

Learn about the regulatory structure in Taiwan and major medical device regulations.view all

市場調査 | 1 page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Use this calculator to see how many calendar days it usually takes the US FDA to clear medical devices with the same Product Code.view all

チャート | Interactive Calculator

In this white paper, we discuss how to determine if your wearable product is considered a regulated medical device by the US FDA.view all

記事 | 7 pages

This video about the United States medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

A set of standards published by UL to address medical device cybersecurity issues will soon be adopted. In this one hour webinar, we discuss various aspects of medical device cybersecurity and how the new UL 2900 standards map to FDA guidance. watch now

Webinar | 1 hour

Learn about the Unique Device Identification (UDI) regulation, how to obtain a UDI number, compliance deadlines, and more.view all

記事 | 5 pages

This video series about the United States' medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 24 minutes

This chart illustrates the steps in the US FDA's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

US FDA 510(k)s have unique content and format requirements. Get an overview of preparing and submitting a 510(k).view all

記事 | 10 pages

Correct classification of a medical device is critical for identifying its proper regulatory route in the United States.view all

記事 | 13 pages

This video describes key aspects of the FDA UDI system, why it is necessary, benefits, and when and how device manufacturers need to comply.view all

ビデオ | 5 min

Does your medical device contain animal or human cells or tissues? Learn about FDA requirements for these products.view all

記事 | 6 pages

In this video, we discuss what medical device companies should do (and what not to do) before, during, and after a random FDA audit. view all

ビデオ | 4 minutes

The US is the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission.watch now

Webinar | 1 hour recording

This white paper provides a high-level overview of the US FDA 21 CFR Part 820 and the implementation process, including timelines and strategies.view all

記事 | 8 pages

In a 510(k) submission, what testing is required by the FDA to clear the device? While testing requirements are easy to determine for some devices, other devices require intensive research.view all

記事 | 24 pages

When preparing a 510(k) submission for a device labeled as sterile, you should carefully consider which sterilization method to use because it will affect the FDA’s expectation.view all

記事 | 7 pages

In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.view all

記事 | 5 pages

In this video, we’ll take a look at 21 CFR Part 820, including an overview, key players, important sections, and how to maintain compliance.view all

ビデオ | 11 min

In this white paper, we discuss US regulations for wireless medical devices, including submission requirements, risk management, and more.view all

記事 | 6 pages

This paper describes exactly what to expect from a random FDA audit and how to prepare for the inspector's arrival in a concise checklist.view all

記事 | 9 pages

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.view all

記事 | 6 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Discover guidelines, tips, and other useful information about corresponding with the FDA about the clearance of your medical device.view all

記事 | 6 pages

Learn about substantial equivalence, which is the key to getting your Class II medical device cleared for sale by the US FDA.view all

記事 | 7 pages

This short video covers FDA classification, how to use the classification database, and useful tips for classifying your medical device.view all

ビデオ | 7 min

Learn about usability engineering studies, including FDA requirements, standards, and how to conduct a usability study.view all

記事 | 7 pages

Are you ready to launch your mobile medical app in the United States? Depending on the functionality of your app, you might need clearance from the US FDA.view all

記事 | 7 pages

Thinking about entering the US market for the first time? Understanding the FDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter the US market.view all

市場調査 | 1 page

This whitepaper discusses how to bring a novel device to the US market, including common pathways, exemptions, and the de novo process.view all

記事 | 8 pages

How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.view all

市場調査 | 11 pages

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.view all

記事 | 16 pages

This white paper addresses Purchasing Controls, one of the biggest QSR compliance vulnerabilities for medical device companies selling in the US.view all

記事 | 9 pages

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.view all

記事 | 8 pages

A brief look at the United States' medical device market, including potential opportunities and obstacles for manufacturers.view all

市場調査 | 1 web page

Learn about the regulatory structure in the United States and major medical device regulations.view all

市場調査 | 1 page

This white paper US quality assurance requirements for human clinical studies and breaks down the key elements compliant study.view all

記事 | 5 pages

ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.view all

記事 | 12 pages

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This white paper discusses potential strategies for achieving global market compliance for your device.view all

記事 | 10 pages

Learn about the FDA 510(k) process in this informative page from Emergoview all

市場調査 | 1 page

ISO 13485:2016 provides an international QMS standard and introduces notable changes, particularly in the area of risk management.view all

記事 | 16 pages

In this recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body.watch now

Webinar | 1 hour

This webinar will help guide you toward a better HFE approach to medical device design and development.watch now

Webinar | 1 hour

This white paper discusses requirements and best practices for translating device labeling and Instructions for Use (IFU).view all

記事 | 8 pages

This white paper provides an overview of new risk requirements and considerations for devices companies under the new standard.view all

記事 | 12 pages

This short video covers the 6 biggest changes in the new ISO 13485:2016.view all

ビデオ | 5 minutes

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.view all

記事 | 6 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

It's not always clear what regulations apply to software. Regulatory authorities across the globe have provided little (or confusing( guidance, leaving developers to question: When is software considered a medical device?view all

記事 | 6 pages

In this recorded webinar, we discuss how risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will have to change how they integrate it with their quality systems.watch now

Webinar | 1 hour

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This white paper discusses potential strategies for achieving global market compliance for your device.view all

記事 | 10 pages

This white paper discusses regulatory considerations for 3D printed medical devices in various markets.view all

記事 |

This table gives you an idea of how much money is spent on healthcare in various countries worldwide, and who pays for it.view all

市場調査 | 1 page

In this video, learn about medical device labeling symbols, their meanings, and how they communicate important product information.view all

ビデオ | 11 min

Learn about the standards, requirements, and benefits of medical device labeling and symbols. Includes a list of common symbols and meanings.view all

記事 | 7 pages

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.view all

記事 | 16 pages

Emergo conducted a survey on the impact of currency changes (increase/decrease of the US Dollar) on medical device sales and profitability worldwide.view all

市場調査 |

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.view all

記事 | 8 pages

In this free webinar, we will outline how to comply with sterile medical device package testing requirements in EN ISO 11607.watch now

Webinar | 1 hour

What is a 510(k)? Or ISO 13485? or a form 483? ANVISA, AIMDD, Compentent Authority ... all these industry terms and more are available in this quick glossary.view all

 

Having a dedicated regulatory compliance page is useful to prospective customers, end users, distributors and regulatory officials. This sample page shows how you could display your company's compliance details.view all

市場調査 | 1 web page

The Global Medical Device Industry Outlook contains unique insights and expectations for the coming year from industry professionals around the world.view all

市場調査 | 14 pages