2017, 2026, 2027 and Manufacturing

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Manufacturing

Staying on Top of MDR, IVDR, and Surveillance Requirements With Cloud QMS

Arena Solutions

JUNE 29, 2023

The Importance of Post-Market Surveillance in Medical Device Manufacturing Manufacturers of medical devices must carry out post-market surveillance once they are commercially available, according to regulatory authorities in the majority of markets, including the United States and the European Union (EU).

Resource Reduction

Resource Reduction Europe Manufacturing Quality

How to Classify Your Medical Device Under the EU MDR and IVDR

Arena Solutions

AUGUST 7, 2023

no notified body involvement) under the IVDD as follows: • Class D devices: May 26, 2026 • Class C devices: May 26, 2027 • Class B and Class A sterile devices: May 26, 2028 STEPS FOR CLASSIFYING YOUR MEDICAL DEVICE UNDER THE EUROPEAN REGULATIONS 1. MDCG 2021-24 Guidance on Classification of Medical Devices MDCG 2020-16 rev.

How To

How To Quality Manufacturing Procurement Examples

Supply Chain Brief

Staying on Top of MDR, IVDR, and Surveillance Requirements With Cloud QMS

How to Classify Your Medical Device Under the EU MDR and IVDR

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