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...