Takeaways from the MassMEDIC Regulatory Roundup Review
Check out Laurie's take-aways from the MassMEDIC Regulatory Roundup Review. A must-read on latest topics for medical device development.
Takeaways from the MassMEDIC Regulatory Roundup Review
FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers
Conducting an Aseptic Presentation Study
FDA Guidance on the Q-Submission Program
A Summary of Risk Management Tools for Human Factors
Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021
FDA Final Rule on the Use of Symbols in Labeling
Updates from the FDA CDRH Human Factors Team 2019
Update on Hospital Access Challenges
FDA/CDER Workshop Highlights
FDA Draft Guidance - Comparative Use HF Studies in an ANDA