FAQ: CSV, CSA, and Why the Paradigm Shift This FAQ curates many questions from our customers and attendees to our various webinars with the FDA on the CSA Guidance. Sandy Hedberg - February 2, 2022 Blogs Biotech, CMO, CRO, Medical Device, Pharma Regulatory
Key differences in the requirements for SFDA UDI and US & EU UDI Blog article topic: Key differences in the requirements for SFDA UDI and US & EU UDI. Jay Crowley - January 29, 2022 Blogs Medical Device Manufacturing, Regulatory
Q&A: UDI Registration in EUDAMED Blog article written from the Q&A during the UDI Registration in EUDAMED webinar. Jay Crowley - January 29, 2022 Blogs Medical Device Regulatory, Safety
FDA Perspectives on Cloud Technologies Watch Session 3 of USDM's virtual event with FDA insights on cloud technologies, CSA guidance updates, and case studies in modern automation. Jim Macdonell - January 28, 2022 Videos Biotech, CMO, CRO, Medical Device, Pharma Information Technology, Regulatory
Your Compliance and Technology Today Watch replays from USDM’s Forward-Thinking GxP Compliance & Process Optimization event. Learn about compliance maturity, IT roadmaps, and process harmonization. Roger Davy - January 28, 2022 Videos Biotech, CMO, CRO, Medical Device, Pharma Information Technology, Regulatory
Medical Device Company Updates 450 QMS SOPs in time for EU MDR Case study on Medical Device Company Updates 450 QMS SOPs in time for EU MDR. Jim Macdonell - January 21, 2022 Case Studies Medical Device Regulatory, Safety
