MDCG Guidance on Investigator’s Brochure: Labeling
The new article describes in detail the approach to be applied with respect to labeling for medical devices undergoing clinical evaluation.
The new article describes in detail the approach to be applied with respect to labeling for medical devices undergoing clinical evaluation.
This article provides insights into 21 CFR Part 820, including an overview of the regulation, its requirements, and compliance strategies. Table of Contents The US Food and Drug Administration (FDA) is responsible for regulating medical devices marketed in the United...
The new article describes in detail the approach to be applied with respect to the changes to existing entries due to the new classification rules. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
The new article provides a brief overview of the regulatory status of active medical devices by TGA, the regulatory agency of Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
Katrina is a U.S. medical device regulations consultant on the east coast with in-depth knowledge of the Medical Device Industry. Katrina has been a consultant with RegDesk for a while now and we recently had the chance to catch up! REGDESK: Did you have any...