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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.
Europe

AEMPS - Spanish Agency of Medicine and Sanitary Products

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

Europe

Switzerland – Overview of medical device industry and healthcare stats

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

Europe

ISO 10993-1 and Biocompatibility for Medical Devices

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

Europe

Swissmedic - Swiss Agency for Therapeutic Products

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

Europe

Belgium – Overview of medical device industry and healthcare statistics

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

Europe

UK – Overview of medical device industry and healthcare statistics

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

Europe | Medical Devices

IGJ - The Dutch Health and Youth Care Inspectorate

Learn about the medical device regulatory authority in The Netherlands.

Europe

Czech Republic – Overview of device industry and healthcare statistics

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

CER Complience webinar EMERGO 2018
Europe

WATCH NOW: Ensure Your CER Complies with MEDDEV 2.7/1 v4

In this webinar, we outline what you need to know about writing a compliant EU Clinical Evaluation Report.

Europe

FRANCE – Overview of medical device industry and healthcare statistics

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

Europe

MHRA - UK Medicines and Healthcare Products Regulatory Agency

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

Europe

In-Depth: Europe CE Marking Medical Device Approval and Compliance

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

Map of Europe where CE Mark is required
Europe

European Countries That Require CE Marking

The European Union comprises 28 countries that require CE Marking. There are 4 additional countries which are not part of the EU, but which also require CE Marking.

Europe

Preparing to Change your European Notified Body

This white paper discusses how to find a new European Notified Body for MDR compliance.

Europe

Germany – Overview of medical device industry and healthcare statistics

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

Europe

Classification Borderline: What Constitutes a Medical Device?

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

Europe

Overview of ISO 11135:2014 and Medical Device Sterilization

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

Europe | Medical Devices

The Role of Eudamed under the MDR and IVDR

In this white paper, you will learn about the role of Eudamed under the new MDR and IVDR.

Europe

Ireland – Overview of medical device industry and healthcare statistics

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

Europe | Medical Devices

Medical Device Labeling, Standards and Symbols

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

Europe

Clinical Investigational Studies in Europe

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

Europe

How to Select and Change a Notified Body in Europe

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

Europe

ITALY – Overview of medical device industry and healthcare statistics

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

Europe

Medical Device Clinical Evaluation Reports for CE Marking

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.

Europe | Medical Devices

Conformity Assessment Routes under the EU Medical Devices Regulation (MDR 2017/745)

Download this white paper for an in-depth look at conformity assessment options under the new MDR.

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

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.

Europe

Netherlands – Overview of medical device industry and healthcare stats

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

Europe

EU Medical Device Vigilance Reporting

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.

Europe

Poland – Overview of medical device industry and healthcare statistics

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

Europe

ASNM - French Agency for the Safety of Health Products

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

Learn about basic demographic and healthcare market data on the European Union
Europe

EUROPE – Overview of medical device industry and healthcare statistics

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

Europe

SPAIN – Overview of medical device industry and healthcare statistics

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

Europe

Introduction to Medical Device Labeling Symbols

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

Europe | In-Vitro Diagnostic Devices, | Medical Devices

Unannounced Notified Body Audits & Your Critical Suppliers

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