Feedback and complaints

MDSAP RAs recognize that complaints can provide valuable feedback on the effectiveness of an organization and can be used to improve the program with the customer in mind. As part of standard process, MDSAP AOs and medical device manufacturers are informed when there is a complaint against them so that improvements can be made. The complainant can request that their personal data be kept confidential.

The MDSAP Complaints and Customer Feedback Procedure applies to MDSAP work products, processes, services. When complaints or other feedback is received, MDSAP RAs address the feedback in accordance with this procedure.

Feedback and complaints may be submitted by emailing MDSAP RAs or the MDSAP RAC Secretariat - Contact details are available here.

In line the MDSAP Management Responsibility and Management Review Procedure, the MDSAP RAC receives a report annually to support:

• the review and analysis of trends and recurrences of nonconformities, complaints and recommendations for appropriate remedial action
• where required, provision of final authority on the disposition of any escalated complaints, corrective actions and other issues arising from feedback. At a minimum, all complaints that have not been resolved within 6 months of receipt of the complaint, need to be escalated for RAC review.