Medical device recalls in Canada

Changes to Canadian medical device regulation with respect to recalls: get your procedures ready for Dec 17, 2024. Make sure that the revised requirements are implemented. HC offers a nice flowchart guiding along the recall procedure. For voluntary recalls, your...

Audit hint

Clause 7.3.10 of ISO 13485:2016 requires manufacturer „to maintain a design and development file for each medical device type or medical device family“. During audits I often come across missing design development files. This was often caused by...