Resource Library for Medical Device Professionals

23 total results. Show all resources.

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

White Paper | 16 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 Medical Device Regulation 2017/745 (MDR) will bring substantial changes to the medical device industry. How will this affect your company?download

White Paper | 14 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

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

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

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

White Paper | 12 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

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

White Paper | 9 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

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 | 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

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

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

White Paper | 7 pages

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

White Paper | 9 pages

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

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

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

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.download

White Paper | 7 pages

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 | 10 pages

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

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

White Paper | 9 pages

Regulatory expectations for risk management are increasing - what does this mean for medical device companies?download

White Paper | 9 pages