ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes workshop hosted by the Ministry of Food and Drug Safety (MFDS) and the National Institute of Medical Device Safety Information (NIDS) was held in Seoul Korea on November 13th, 2018.
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes workshop hosted by the Ministry of Food and Drug Safety (MFDS) and the National Institute of Medical Device Safety Information (NIDS) was held in Seoul Korea on November 13th, 2018. The workshop was set to correspond with the ISO TC210, Quality management and corresponding general aspects for medical devices, Annual meeting in Seoul to maximize access to experts from ISO TC210/WG1. The goal was to provide an opportunity for the attendees to give feedback directly to the experts of WG1 on the current standard, ISO 13485:2016 and ISO 13485:2016 - Medical devices - A practical guide, and any future revision considerations. Korea MFDS also shared their guidance using the standard in 3D printing of medical devices.
Thanks to the excellent support of MFDS, NIDS, and the speakers, all the presentations are publicly available at the links below.