In a rapidly evolving technology and regulation landscape, Computer System Validation (CSV) is often associated with delays, inflated costs, and inefficiencies. Draft FDA guidance on Computer Software Assurance (CSA) presents an opportunity to reshape validation and enhance medical device quality, availability, and safety.
Read CooperVision and Glaukos' insights on how risk-based validation reduces costs, speeds compliance, and speeds time to market, including:
- Implementation and change management
- Key factors for successful implementation
- Achieving efficiency and cost reductions