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 [...]
Self-Certification for CE Mark – An Overview
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game [...]
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 [...]
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 [...]
CER Writer | How to Find The Best CER Medical Writers & Strategy
Are you shopping for CER writers? Or perhaps trying to evaluate if this is [...]
Clinical Evaluation Consultant: What to Know Before You Hire
Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start [...]
Free EU MDR Templates – Download Here
Before you begin (or continue your EU MDR Journey), make sure you're operating off [...]
What Is a Legacy Device, and What Do Manufacturers Need to Know About It?
The MDR is a sweeping reform of medical device regulation in Europe that aims [...]
Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR
Under the European Medical Device Regulation (EU MDR 2017/745), manufacturers are required to conduct [...]
Systematic Literature Reviews
The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation [...]