on 20 March 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
We used the publication of the final rule amending the US Quality System Regulations (QSR) as an example in our recent blog titled Enhancing Competitiveness in MedTech: Smart Strategies with Regulatory Intelligence. Here we will look at the final rule, and its implications in a...
Read Moreon 6 February 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
What is regulatory intelligence? Ok, so what on earth are we talking about when we say regulatory intelligence? There are no formal definitions for regulatory intelligence in regulations or standards relating to medical devices or in vitro diagnostic devices. Without delving...
Read Moreon 16 November 2023 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
Introduction We have previously talked about the upcoming 2024 EU deadlines for QMS compliance and notified body applications for the EU MDR 2017/745 (5 Essential Tips for EU MDR Compliance and How to Meet the EU's 2024 MDR Deadlines), but what is needed beyond that? What if you...
Read Moreon 17 July 2023 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
Introduction Regulation 2023/607 removed the May 2024 transition deadline for medical devices transitioning from MDD/AIMDD to MDR 2017/745. The end of the transition period was pushed back to 2026, 2027 or 2028, depending on the classification of the device.
Read Moreon 17 December 2021 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also...
Read Moreon 14 December 2021 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
What do we know so far about post-Brexit medical device regulation? With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge....
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