Sara Dyson, Medmarc’s Assistant VP of Loss Control, will speak at the Medical Device Summit, “Supplier Controls and Quality Management Conference 2012” at the Marriott Wardman Park in Washington, DC on January 19-20, 2012.
FDA has steadily increased its enforcement focus on supplier controls – a critical potential weak link in medical product manufacturing. Manufacturers can outsource goods and services but not regulatory responsibility or product liability.
Devices pose a unique set of challenges because of the exceptionally wide range of supplied products and services and a reliance on suppliers from other fields, who have limited knowledge of medical risk factors and regulatory requirements.
Who Should Attend
Quality and Regulatory Affairs professionals, Supply Chain managers, Purchasing, and others involved in vendor selection and auditing from medical device companies. Also, senior management, quality, regulatory, business development personnel from suppliers to the medical device industry.