Meddev 2.7 1 Rev 4: Guidelines for Literature Search
MEDDEV 2.7.1 Rev. 4 remains the most important technical guidance document for conducting literature searches within the European medical device regulatory framework.…
20 Nov 2025
ISO Standards for Medical Devices: What they are and When you Need Them
The whole point of medical devices is to improve patient safety and patient quality of life. That's it, that's the gist. To…
20 Nov 2025
Self-Certification for CE Mark – An Overview
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in…
20 Nov 2025
Medical Device Reporting (MDR): How to Report Problems to the FDA
Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen.…
20 Nov 2025
The DIY Clinical Evaluation Report – Do You Really Need A CER Writer?
So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing…
20 Nov 2025
CER Writer | How to Find The Best CER Medical Writers & Strategy
The best CER medical writers combine a life-sciences or clinical background with substantial applicable clinical experience, a track record of CERs accepted…
20 Nov 2025
Clinical Evaluation Consultant: What to Know Before You Hire
Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start that new Clinical Evaluation Report (CER) project for…
20 Nov 2025
PMCF Plan EU MDR: What You Need and How to Create It
Post-market clinical follow-up, or PMCF, is the proactive, ongoing collection of clinical data on a device after it reaches the EU market, used…
20 Nov 2025