Resource Library for Medical Device Professionals

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58 total results. Show all resources.

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

White Paper | 14 pages

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

White Paper | 16 pages

Europe's new In Vitro Diagnostic Regulation (IVDR) will bring significant regulatory changes for IVD manufacturers selling in Europe.download

White Paper | 16 pages

Medical device companies selling in Europe are preparing to transition to the new Medical Device Regulation (MDR). The transition deadline seems distant, but there are a lot of factors to consider when coordinating and planning the transition strategydownload

White Paper | 10 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

Videos and Webinars | 1 hour live webinar

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

Process Flow Chart | 2 pages

In this 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

Videos and Webinars | 1 hour live webinar

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

Process Flow Chart | 2 pages

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

White Paper | 6 pages

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

Videos and Webinars | 1 hour

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

Videos and Webinars | 7 min

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

Videos and Webinars | 4 minutes

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.watch now

Videos and Webinars | 29 minutes

Risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will have to approach risk management controls in a new way, and change how they integrate it with their quality watch now

Videos and Webinars | 1 hour webinar

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

White Paper | 9 pages

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

White Paper | 8 pages

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

 

In this 35 minute recorded webinar from September 2016, we outline the most important MDR changes you need to know about.watch now

Videos and Webinars | 35 min

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

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

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

Device Regulation | Downloadable PDFs

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

Videos and Webinars | 4 minutes

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

 

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

 

What if you have two medical devices that are combined and used together? Learn how Europe regulates device systems.download

White Paper | 3 pages

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

 

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

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

 

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

Process Flow Chart | Interactive Page

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

White Paper | 5 pages

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

White Paper | 5 pages

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

 

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

Videos and Webinars | 21 minutes

Vigilance reporting is confusing for many manufacturers in Europe but it is critical to comply with vigilance requirements. download

White Paper | 5 pages

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

 

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

White Paper | 8 pages

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

Videos and Webinars | 11 min

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

White Paper | 5 pages

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

 

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

White Paper | 7 pages

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

 

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.download

White Paper | 4 pages

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

 

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

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

 

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

 

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

 

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

 

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

White Paper | 5 pages

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

 

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

White Paper | 8 pages

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

 

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

 

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

 

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

 

Medical device suppliers and subcontractors are subject to on-site unnanounced Notified Body audits. Learn how to stay in compliance.download

White Paper | 4 pages