EU Clinical Trial Regulation: What you Need to Know
For manufacturers, clinical trials or at least the protocol are already planned and set [...]
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 [...]
Meddev 2.7 1 Rev 4: Guidelines for Literature Search
MEDDEV 2.7.1 Rev. 4 remains the most important technical guidance document for conducting literature [...]
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 [...]
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 [...]
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 [...]
Navigating Global Medical Device Regulations
Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device [...]