Arjan van Drongelen, former convenor of ISO/TC 210/WG6, received the ISO Certificate of Excellence for his efforts in driving the development and publication of ISO/TR 20416:2020, an ISO Technical Report on post-market surveillance (PMS) for manufacturers.
On May 31, 2022, Arjan van Drongelen, former convenor of ISO/TC 210's WG6, finally received the ISO Certificate of Excellence signed by Sergio Mujica, ISO Secretary General, and Peter Linders, chair of ISO/TC 210. Arjan received this because of his efforts in driving the development and publication in July 2020 of ISO/TR 20416, an ISO Technical Report on post-market surveillance (PMS) for manufacturers. Phil Brown also received such a certificate. In his role as deputy convenor of WG6, he was instrumental in helping resolve the many comments submitted to drafts during the development of the Technical Report. Because of COVID-19, there was a 2-year (!) delay in handing over the certificate to Arjan.
PMS is a key element in the medical device regulatory framework. Often underestimated, a good post-market surveillance system helps in getting innovative devices on the market early - by keeping the pre-market assessment manageable - while maintaining a high level of safety of the devices. Both ISO 13485 and ISO 14971 emphasize the importance of PMS but do not provide detailed practical information. ISO/TR 20416 fills this gap.
Before Arjan stepped out of WG6, he - together with the WG - initiated two preliminary work items (PWIs) for WG6. In the meantime, both PWIs received massive support by the TC membership, and we are anxiously awaiting the new WG6 leadership to help define how to proceed.