Resource Library for Medical Device Professionals

43 total results. Show all resources.

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

Process Chart | 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.download

White Paper | 7 pages

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

Video | 4 minutes

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

Video | 5 min

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

White Paper | 5 pages

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

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

Device Regulation | Downloadable PDFs

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

White Paper | 10 pages

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

Process Chart | 2 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.watch now

Video | 24 minutes

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

White Paper | 13 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. watch now

Video | 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.download

White Paper | 8 pages

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

White Paper | 6 pages

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

White Paper | 8 pages

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

Video | 7 min

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.download

White Paper | 9 pages

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

White Paper | 6 pages

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

White Paper | 6 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.download

White Paper | 7 pages

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

Service Overview | Varies

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

White Paper | 5 pages

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

White Paper | 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.watch now

Video | 7 min

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.watch now

Video | 11 min

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.download

White Paper | 24 pages

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

White Paper | 6 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.download

White Paper | 7 pages

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

White Paper | 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

Market Data | 1 page

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

White Paper | 10 pages

Read by 50,000+ device professionals worldwide. Stay updated on changes to global medical device regulations.view all

 

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

White Paper | 5 pages

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

White Paper | 12 pages

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

White Paper | 8 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.download

White Paper | 16 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

Market Data | 11 pages

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

White Paper | 9 pages

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

Market Data | 1 web page

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

Process Chart | Interactive Page

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

Market Data | 1 page

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

Market Data | 1 page