May 25, 2022
Supply Chain Management
Outsourcing goods and services can be efficient and economical, but the sometimes long and complex supply chains in medical device manufacturing pose challenges in maintaining appropriate quality and control. Manufacturers retain full regulatory responsibility, product liability, and brand name vulnerability, and must carefully qualify and oversee suppliers. FDA has always been aware of risks that arise from poor supply chain management, and the EU Medical Device Regulation imposes strict new requirements on economic operators. What good practices will help manufacturers ensure that they have selected the right suppliers and established relationships that will guarantee the quality of their products and compliance with all regulatory and company requirements?