Resources (2024)

Pathway to MDSAP Whitepaper QMS Audit Readiness In-house Tests Under EU IVDR – How to Best Meet Your IVDR Deadlines Developing HFE Strategies to Meet Global Regulations US FDA Breakthrough Device (BTD) and Safer Technologies Program (STeP) Designations Recent Brazil Regulatory Updates Regulation EU 2023/607 Frequently Found Issues Integrated Risk Management Throughout Device Lifecycle Guide to US FDA Requirements for Novel and Innovative Medical Devices U.S. FDA Pre-Submissions US FDA and MDSAP Inspections for Medical Device Manufacturers Medical Device Registration Pathway and Regulatory Requirements in the Chinese Market