We are delighted and proud to announce that QAdvis Group has achieved ISO 13485:2016 certification. This is a major milestone and demonstrates our commitment to provide high quality consulting services and we are now better positioned to consistently meet and exceed our clients’ expectations.

Purpose of implementing a device identification system is to improve patient safety by making the traceability of devices more efficient and simplify a FSCA (Field Safety Corrective Action) e.g. recall of devices. In parallel, the post-market safety-related activities for devices will also be more robust and allow a better monitoring by the competent authorities. UDI, […]