• A single audit is used in lieu of multiple separate audits or inspections by participating RAs or their representatives. Therefore, for many medical device manufacturers, the MDSAP Pilot reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities.
• Additionally, as a longer term goal, it is expected that the program will enhance confidence in the reliability of third party audits, that more RAs will join the program, and that other RAs will use information made available through the program to limit the need for additional audits.
• Some participating RAs will use MDSAP Pilot audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorization.
• The MDSAP Pilot is expected to improve the predictability of audit outcomes.
• Enrolling in the MDSAP Pilot may be seen as evidence of a medical device manufacturer’s commitment to quality management systems for product quality and regulatory compliance.
• Like in any third party auditing program, the medical device manufacturer is free to choose among all authorized AOs to perform the audits. Routine audits are announced and planned with the manufacturer.
