Medical Device

Technical

Medical Device UDI Components Management in the European Union

1 July 2021

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...

iSpeak Blog

Use of Safety and Performance to Determine Substantial Equivalence – FDA Issues New Guidance for Medical Devices

7 October 2019

FDA’s efforts to continue streamlining approval pathways for medical devices was expanded when, on September 20, 2019, the Agency issued new Final Guidance as a means to help manufacturers understand how the Agency will determine substantial equivalence...

Training

Requirements for Computerized Systems Validation and Compliance

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...

Medical Devices and in Vitro Diagnostics Products 21 CFR Part 820

GMP Regulation Handbooks

GMP Regulation Handbook: Medical Devices, 21 CFR Part 820

1 April 2017

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