Revalidation of software

Audit hint: Validation of software used within the quality management system as per ISO 13485 is not new and most of the companies did their homework. However, keep in mind that any change to such software must be assessed if revalidation is required. Just recently I...

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...

Design Validation

Do you know the following sentence? „Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be...