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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

329 total results. Use the filters to narrow down the results.
South Korea

Medical Device Consulting Services for South Korea

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.

Fill out our short form to request information about South Korea
South Korea

Get smart about South Korea in 1 hour

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.

South Korea

What To Expect From Your Regulatory Representative

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.

Compare the time, cost and complexity of getting regulatory approval for medical devices
South Korea

Time, Cost and Complexity of Regulatory Approvals Worldwide

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

South Korea

MFDS - South Korea Ministry of Food and Drug Safety

Learn about the regulatory structure in South Korea and major medical device regulations.

Learn about the South Korean MFDS regulations which apply to medical devices
South Korea

South Korea Medical Device Regulations

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

Download the free chart: Taiwan Regulatory Approval Process for Medical Devices
Taiwan

Taiwan TFDA Regulatory Approval Process for Medical Devices

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

Taiwan

Introduction to Taiwan's Medical Device Approval Process

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

Taiwan

Taiwan TFDA Medical Device Registration Requirements

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

Taiwan

Medical Device Consulting Services for Taiwan

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.

Taiwan

In Depth: Taiwan Medical Device Approval and Compliance

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

Learn about the Taiwanese Department of Health regulations which apply to medical devices
Taiwan

Taiwan Medical Device Regulations

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

Taiwan

TFDA - Taiwan Food and Drug Administration

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

Compare the time, cost and complexity of getting regulatory approval for medical devices
Taiwan

Time, Cost and Complexity of Regulatory Approvals Worldwide

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

United States | Digital Health Products, | Health and Wellness Products

Wearables vs. Regulated Medical Devices under the US FDA

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

Our 510(k) calculator looks how long it has taken the FDA to clear specific devices during the past five years.
United States

How Long Will It Take My 510(k) to be Cleared by the FDA?

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

United States

Introduction to US FDA Medical Device Regulatory Process

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

United States

Understanding the US FDA UDI Regulation

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

United States

Understanding the US FDA Device Classification System

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

United States

In Depth: US FDA Medical Device Registration and Compliance

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

Register for our webinar: Mapping UL 2900 Cybersecurity Standards to FDA Guidance
United States | Digital Health Products

WATCH NOW: Mapping cybersecurity standards to FDA guidance

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.

United States

Preparing a US FDA Medical Device 510(k) Submission

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

Download the Chart on the Medical Device Approval Process in the USA
United States

US FDA Registration Process for Medical Devices

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

United States

In Depth: The US FDA 510(k) Clearance Process

In this 8-minute video, we discuss the steps you should take to prepare and submit a 510(k) to the US FDA.

United States

Introduction to the UDI System in the USA

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

Learn about the US FDA regulations which apply to medical devices
United States

USA Medical Device Regulations

A comprehensive list of medical device regulations in United States with links to the original documents.

United States

Implementing a Medical Device Post-Market Surveillance Program

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

United States

Early Communication with the FDA

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

United States

What to Expect During an FDA QSR Inspection

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.

United States

Medical Device Testing Requirements for 510(k) Submissions

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.

United States

How to Prepare for an FDA Inspection

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

Download our white paper on Usability Studies and the US FDA
United States | Combination Products

Usability Studies and the US FDA

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