Rene Clement

Articles by this author (72)

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• Classification of medical devices : The New MEDDEV Guidelines has just been published
• 2021-10-14 EU Commission proposal for the gradual roll-out of the IVDR.
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• ISO 13485 audit – MDR & IVDR
• 2024-11-08 EU Parliament adopted a resolution for an Urgent need to revise the medical devices regulations
• Switzerland: Obligations for authorized representatives, importers and distributors
• Class 1 Reusable Surgical Instruments : Mandatory Conformity Assessment by a Notified Body