September 6, 2022
The In Vitro Diagnostic Regulation has held the center of the medical device manufacturers' community's attention for a while now. While most manufacturers know of it, many details can still be confusing. Here are the [...]
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? [...]
July 24, 2019
Cost Savings of Literature Searches in Your CER Introduction We recently had a client that wanted to weigh the option of outsourcing their entire CER project overseas to more attractively [...]
July 22, 2019
Medical Device Regulations – Links You Should Be Aware Of Overview These are the most important regulations to be aware of governing Medical Devices in the European Union. If you [...]
July 21, 2019
CE Marking Process in the European Union Introduction This article will detail the various steps you will need to take for an entire CE Certification cycle for your product. [...]
November 18, 2016
The Literature Review: Key Component to Successfully Navigating the MDR A New Emphasis On Research It’s obvious that the impending European Commission’s implementation of the [...]