Free EU MDR Templates – Download Here
Before you begin (or continue your EU MDR Journey), make sure you're operating off [...]
The UK MDR and The EU MDR: What Are The Differences?
UK MDR is the primary standard that mandates requirements for anyone selling medical products in [...]
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 [...]
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 [...]
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it [...]
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It's pretty important to get the regulations right, [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof [...]
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final [...]
Unexpected Documents You Might Need for Your Clinical Evaluation Report
Medical device regulation is important. Not just because we work with them. But because [...]
Software as a Medical Device
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical [...]