EU Clinical Trial Regulation: What you Need to Know
For manufacturers, clinical trials or at least the protocol are already planned [...]
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
The European Union Medical Device Regulation (EU MDR) has set higher standards for medical [...]
Free EU MDR Templates – Download Here
Before you begin (or continue your EU MDR Journey), make sure you're operating off [...]
Post-market Clinical Follow-up (PMCF): What you Need and How to Get It
One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) [...]
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 [...]
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 [...]
Self-Certification for CE Mark – An Overview
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Literature Search
The MEDDEV 2.7.1 is the most important technical guidance document for literature search under [...]
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 [...]
In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so that you can market your [...]