The publication of ISO 13485:2016 in March last year reinforced the notion of control of supply chain for Medical Device manufacturers. With a clear reinforcement of the risk-based approach in the entire ISO 13485:2016, it is no exception that the Purchasing section (7.4) includes new provisions to strengthen Supplier control. Requirements are mostly written towards the medical devices legal manufacturer to control its suppliers, however it is critical that suppliers are also aware about them as they could also be ISO 13485 certified. The updated standard gives more details about what companies shall consider in the process of evaluation, selection and monitoring of their suppliers. It not only amends the management of Supplier relationships, but also puts in perspective the whole process of supplier selection.
Join LNE/G-MED and Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality at LNE/G-MED North America, Inc., to understand why Notified Bodies need to ensure control of Critical suppliers by Medical Device manufacturers, how ISO 13485:2016 impacts Critical Suppliers’ processes. You can tune to LNE/G-MED North America’s upcoming free webinar on Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives.