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MDR PMS and PSUR requirements white paper
PMS & PSUR requirements under the EU MDR
Medical device post-market surveillance (PMS) activities have already been described in the European Medical Device Directive (93/42/EEC) and are
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Cleaning, disinfection, and sterilization of reusable medical devices
Cleaning, disinfecting, and sterilizing medical devices are critical activities for preventing the incidence of healthcare associated infections (
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EU MDR delay white paper
MDR One-year Delay: Implications for medical device manufacturers
In February 2020, the first European countries began to be affected by the COVID-19 virus. During March, the rest of the pack followed and Europe
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How ISO 13485:2016 Impacts Medical Device Companies
ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also
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Understanding Europe's New Medical Device Regulation - MDR 2017/745
You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What
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Understanding the EU IVDR white paper by Emergo by UL
Understanding Europe's New IVDR 2017/746
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring
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Emergo webinar - medical device design controls January 2019
ISO 14971 Risk Management for Medical Devices: The Definitive Guide
The purpose of this guide is three-fold: To leave you with an understanding of what is expected from medical device regulators regarding Risk
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Regulations for Companion Diagnostics in the US and EU
Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision
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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
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