FDA 483 REMEDIATION: VERIFICATION AND VALIDATION

A medical device manufacturer received a FDA 483 concerning their procedures and practices regarding design verification and validation. Dellshire experts completed a deep dive to fully understand the breadth and scope of the issues and provided a comprehensive plan to address the company’s needs. Procedures for Design Controls were remediated as well as procedures for other key aspects of their business including Risk Management, CAPA, Complaint Management, and Document Control. Once all procedures were approved and implemented, training was conducted and a retrospective review and qualification of design changes was completed in accordance with these procedures. Completion of these tasks and providing this service allowed the company to address the concerns of FDA, improve the integrity of their quality system and reinforce the quality of their products in the market.