Resource Library for Medical Device Professionals

21 total results. Show all resources.

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

문서 | 16 pages

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

문서 | 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

문서 | 14 pages

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

문서 | 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

문서 | 5 pages

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

문서 | 12 pages

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

문서 | 6 pages

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

문서 | 6 pages

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

문서 | 9 pages

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

문서 | 9 pages

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

문서 | 12 pages

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

문서 | 5 pages

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

문서 | 7 pages

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

문서 | 5 pages

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

문서 | 14 pages

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

문서 | 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.view all

문서 | 16 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

문서 | 5 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

문서 | 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

문서 | 10 pages

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

문서 | 7 pages