Still Maintaining Duplicate MDD/IVDD- and MDR/IVDR-Compliant Documentation?

Your regulatory team is über-organized and has been maintaining duplicate sets of technical documentation for your legacy devices, in compliance with the old MDD 93/42/EEC and IVDD 98/79/EC and the new MDR 2017/745 and IVDR 2017/746. You’re doing this because even though your device has a valid CE Marking certificate that expires between 2023 and 2025, the MDR and IVDR are now the law of the land and you need to manage two sets of documents to maintain compliance with […]
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