Latest Publications
January 8, 2020
MDCG's Guidance document, released in July 2020, introduces and details the essential requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]
August 22, 2019
Part 2: Vigilance and Incident Reporting In the second post of our Post Market Surveillance series we’re going to dive into incident reporting and vigilance. This section of MDR deals with how your firm [...]
August 19, 2019
Post Market Surveillance in MDR There are only a handful of explicit things that you HAVE to do under MDR for PMS, however there are a lot more things you SHOULD be doing to [...]
July 26, 2019
MDR Date Of Application Is Approaching Introduction The May 2020 deadline outline in Reg 2017/745 is a cutoff for new filings under MDD, the previous regulation. If your product is [...]
July 25, 2019
Periodic Safety Update Reports: Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? [...]