Systematic Literature Reviews
The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation [...]
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its [...]
Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance
Guide - MDCG endorsed documents and other guidance documents. The majority of documents on [...]
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one [...]
Top 10 Literature Search Tools Every Medical Writer Should Know
Medical writing is hard. It's tricky, technical, and sometimes exceptionally tedious. Suppose you chose [...]
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 [...]
Building Your PMS Templates
This document intends to cover a comprehensive framework for each of your products. Use [...]
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 [...]