Regulatory Requirements and Standards for Medical Device Validation & Verification

Presented by: Ritam Priya, Consultant, MDRQ Consulting Manufacturers (including software developers) need to gather objective evidence of performance, safety and efficacy to support both their premarket authorization/registration in different markets and postmarket changes. Regulatory requirements are defined by different regulators for product compliance and different committees like ISO, AAMI and IEC that develop standards to […]