Resources

All regulatory process charts are available to download from Regulatory Affairs Management Suite (RAMS).
Log into RAMS or create your free account to download this information.

LOG INTO RAMS

Get unlimited access to the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

Preparing a European CE Technical File for a Medical Device
Want to sell your medical device in Europe? If the answer is yes, you probably have a lot of questions about one of the key elements of the European
Read More
Watch our recent webinar on the European In Vitro Diagnostic Devices Regulation
WATCH NOW: Europe's New IVDR 2017/746
Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The current In Vitro Diagnostic
Read More
Introduction to Clinical Evaluation Reports (CER) for Europe
Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device,
Read More
Implementing a Medical Device Post-Market Surveillance Program
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system
Read More
ISO 13485:2016 and the new Risk-based Approach
The new ISO 13485:2016 quality management system standard for medical devices introduces lots of new changes and concepts. However, its emphasis on
Read More
Learn about the European Directives and Regulations which apply to medical devices
Medical Device Regulations in Europe
All regulatory documents shown below were published by the European Parliament or European Commission. Please help us maintain this list by reporting
Read More
Register for our webinar: Post Market Surveillance & PMCF under the European MDR
WATCH NOW: PMS & PMCF under the European MDR
Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) adds to the
Read More
Conducting a medical device PMCF webinar
WATCH NOW: Conducting a Medical Device PMCF Study
The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting structured post-market data
Read More