I stumbled upon a significant idea with regulatory and quality expert Michelle Lott last week. Seize it immediately! Here's that 9-minute conversation. Get or renew your CE mark TODAY! If you prefer reading, the conversation highlights are: Get or re...
A question from group member Mike Murphy QA Consultant, Combination Product Launch at The Medicines Company: Can anyone share experience of change EC-REP address (within the same country or otherwise)? How much time do NCA's allow to remediate IFU's ...
As originally asked by Dan O'Leary President at Ombu Enterprises, LLC The General Safety and Performance Requirements do not mention any specific harmonized standards. However, there are QMS and RMS requirements in various parts of the EU-MDR. No dou...
Medical devices and IVD regulatory expert with a global perspective
Looking through the Final text of the EU MDR, it's obvious that although the familiar rules based classifications, risk based review and 3rd party conformity assessment remain, there's a whole lot of New and the bar is raised much higher. There are m...
Article link below, quick summary of article: Why the regulation was needed, the changes and impacts, NB designations and Brexit updates, and steps to implement this huge change. See: EU MDR 2017/745 – Are You Ready for Big Changes?
Does anybody have a list of European countries Competent Authorities / Ministry of Health that require further communication/declaration/registration once the CE-mark obtained? Thank you for you help!source: https://www.linkedin.com/groups/2070960/20...
CEO and Founder at Regulatory1
EU representative for CE marking: is Israel consider an European address in your point of view?source: https://www.linkedin.com/groups/78665/78665-6161602791837044737