Computer Software Assurance (CSA) Guidance Explore the FDA's CSA guidance for risk-based computer software assurance in life sciences. Enhance compliance, product quality, and patient safety. Sandy Hedberg - February 3, 2022 White Papers Biotech, Medical Device, Pharma Clinical, Information Technology, Manufacturing, Quality Assurance, 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
EU MDR Date of Application Readiness Guide White paper on EU MDR Date of Application Readiness Guide. Jay Crowley - January 17, 2022 White Papers Medical Device Clinical, Manufacturing, Quality Assurance, Regulatory, Research & Development, Safety
USDM Managed Compliance Program Case study on USDM Managed Compliance Program. John Petrakis - January 15, 2022 Case Studies Biotech Manufacturing
Will Your Company Be Ready for the Next Regulatory UDI Database? Blog article topic: Will Your Company Be Ready for the Next Regulatory UDI Database? Jay Crowley - January 14, 2022 Blogs Medical Device Manufacturing, Regulatory
Another Regional UDI Database: Singapore’s UDI Implementation Blog article topic: Another Regional UDI Database: Singapore’s UDI Implementation. Jay Crowley - January 8, 2022 Blogs Medical Device Manufacturing, Regulatory
