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 of and document the performance and safety of…
20 Nov 2025
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It’s pretty important to get the regulations right, since even a single missed data, if significant…
20 Nov 2025
Quality Management System: What ISO Standards Say About QMS
A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and…
20 Nov 2025
Software as a Medical Device (SaMD): EU MDR and FDA Regulatory Overview
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern…
20 Nov 2025
The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a…
20 Nov 2025
Unexpected Documents You Might Need for Your Clinical Evaluation Report
Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat,…
20 Nov 2025
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation…
20 Nov 2025
CER Medical Writer Qualifications for EU MDR: 7 Essential Skills
A strong CER medical writer combines the right academic background, real regulatory experience, and precise technical writing, and meets the specific qualification…
20 Nov 2025