Thank you for allowing us to comment on the proposed MDR Revision text. There are some great revisions which have been done to the MDR regulatory framework. Thank you. Here are my recommendations (also within attached PDF) based on my long-time working experience in medtech as technical file & clinical evaluation writer & evaluator, as RA/ QMS/ Clinical Affairs manager and as senior biomedical engineer working for…
MedTechXperts LLC
Company · Switzerland
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Their record over time
MedTechXperts LLC filed 2 positions between 6 Oct 2025 and 3 Aug 2026, across 1 of the 326 legislative files tracked here, attaching a full position paper 2 times.
What they argued
Thank you for allowing stakeholders of different colors to comment on the MDR Revision. Here are the first recommendations with rest in PDF. (1) Increase the harmonization by recognizing and referring to existing internationally recognized institutions: - IMDRF i.e. align with guidance on Technical File (e.g.
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