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

When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun.  Often this is due to the nature of research itself – one is exploring a concept or design approach that may or may not pan out in the end.  The US...Read More