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 Report 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
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
The UK MDR and The EU MDR: What Are The Differences?
The single biggest difference is that they are no longer the same regulation. Great Britain runs on the UK Medical Devices Regulations…
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
Term Refinement in Literature Search
A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references…
20 Nov 2025
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 to strengthen safety and quality. Recently, the provisions…
20 Nov 2025