The new version of the European medical device directive (Known as MDR) is very much different from the current MDD. While a lot of the spirit of the regulations hasn’t changed, the wording throughout is different. You have to review each word, and match/verify it all. While some of the changes are minor, others are tangibly significant. There are major changes in Post Market Surveillance and Clinical reviews.
Fundamentally everything has changed and you have to review, update and validate everything. This is not an insignificant change for your company. And of course it’s a great opportunity to review your whole regulatory setup and look for streamlining and optimization.
Further, Brexit is creating turmoil and uncertainty that you may need a contingency plan to reduce the risk of your customers.
Cavendish Scott has been helping with regulatory solutions for over 30 years. We take a management system approach so that you not only meet regulations but you are comfortable and confident that you always meet regulations. We create procedures and structured technical files with checklists and tools to ensure a complete and detailed solution that you can be assured meets your regulatory needs.
Although you have until May of 2020, you need to start on your solution now. (if your surveillance assessment is in June then June of 2020 will be too late).
Tell us what your needs are and see how we can help.