Medical Device

Medical Device UDI Components Management in the European Union
Technical
Medical Device UDI Components Management in the European Union

Since 2019, the ISPE France Affiliate’s Unique Device Identification (UDI) Medical Device Work Group has been producing tools to help project stakeholders within the EU or overseas understand and comply with EU regulations of UDIs in medical devices. Some of those tools are highlighted in the article.

Medical Devices and in Vitro Diagnostics Products 21 CFR Part 820
GMP Regulation Handbooks

GMP Regulation Handbook: Medical Devices, 21 CFR Part 820

Regulation Handbook: 21 CFR Part 820: Medical Devices Quality Systems Regulation (formerly known as Current Good Manufacturing Practice for Medical...