All About Signal Detection & Management – Face -Face session at Bengaluru!
A comprehensive training program – Safety Evaluation and Risk Management (SERM)
Quality System regulations for Medical Devices – CGMP
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) […]