Dave M Deroche

Dave conducts audits with a detailed focus on design validation and how effective firms handle and react to device failures and deficiencies in accordance with regulatory compliance. He places great value on the roles and responsibilities of personnel in context with job outcomes, MDR reports, and complaint handling.

FDA Investigator Dave M Deroche shows a keen interest in the adequacy of design validations and documentations associated with devices. He also shows concern about complaint handling procedures and the sufficiency of associated report submissions within the required timeframe. He tends to focus on how firms manage and respond to device failures and specification shortcomings. Additionally, Dave underscores the importance of appropriate personnel training, ensuring job outcomes align effectively with regulatory standards and quality objectives.