EU Clinical Trial Regulation: What you Need to Know
For manufacturers, clinical trials or at least the protocol are already planned and set to go for up to 2023. However, a…
20 Nov 2025
The Post-Market Surveillance Document: Which Ones Do you Need?
It’s not enough to make a device and put it on the market—you must know how people use your product. Therefore, the…
20 Nov 2025
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
A clinical evaluation report checklist for someone writing their own CER covers nine steps: scope and intended purpose, device and equivalence description,…
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
Free EU MDR Templates – Download Here
Before you begin (or continue your EU MDR Journey), make sure you’re operating off of comprehensive templates. This article will cover a…
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
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
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