Medical Device

Technical
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...
Training
This online course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals...
GMP Regulation Handbooks
Regulation Handbook: 21 CFR Part 820: Medical Devices Quality Systems Regulation (formerly known as Current Good Manufacturing Practice for Medical...