Design Approval Requirements and Signatures: Navigating 21 CFR 820 and ISO 13485 Medical device manufacturers often struggle with a fundamental question: What signature requirements apply to design input and design output approvals? Understanding how 21 CFR 820 Design Controls and ISO 13485 address design approvals is essential for achieving both compliance and operational efficiency. This...Read More

German court parks four Volkswagen execs in jail over Dieselgate scandal in which software used to test its vehicles’ pollution emissions was intentionally modified to falsify results.Read More