on 21 January 2022 | By Jonathan Gimbel, PhD, RQM+ Executive Director, Technical Leadership, Clinical & Post-Market Practice
The EU MDR date of application has come and gone, and most manufacturers are well aware of the new requirements. However, awareness does not necessarily equal effective implementation. One of the main challenges of MDR compliance is creating a strategy that integrates the work...
Read Moreon 17 November 2021 | By Jonathan Gimbel, PhD, RQM+ Executive Director, Technical Leadership, Clinical & Post-Market Practice
As guidance committees, manufacturers, and notified bodies continue to interpret the EU MDR, some areas remain fuzzy. Well-established technology (WET) is high on the list of definitions that are disputed as notified bodies seem to have a different interpretation than the...
Read Moreon 27 October 2021 | By Jonathan Gimbel, PhD, RQM+ Executive Director, Technical Leadership, Clinical & Post-Market Practice
The rollout of the EU MDR has created new challenges for medical device manufacturers, including those that have had devices on the market for a long time. One area of increased focus is the need to quantitatively establish the clinical benefits to patients from the device based...
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