UL’s Medical Devices Single Audit Program (MDSAP) helps manufacturers meet the quality management system (QMS) requirements for participating countries with a single QMS audit. MDSAP is based on International Medical Device Regulators Forum (IMDRF) quality system recommendations, and regulators currently participating in the program include the U.S. FDA, Health Canada, the Australian Therapeutic Goods Administration (TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Brazil’s National Health Surveillance Agency (ANVISA).
MDSAP Benefits for Medical Device Manufacturers
For the medical device industry, MDSAP is expected to significantly reduce the audit compliance challenges and timeframes. Specific benefits of MDSAP include:
Harmonization of auditing requirements
- Broader acceptance of audit reports among participating regulators
- Reduced overall auditing time and expense
- Reduced time responding to findings
- Wider choice of third-party audit organizations
- More transparent and consistent oversight by regulators
Similar to other management system audit programs, MDSAP is based on a three-year audit cycle conducted in accordance with the requirements of ISO/IEC 17021:
- Stage 1 Initial certification audit – Review of documentation and overall preparedness. Typically includes a review of the planning documentation.
- Stage 2 Initial certification audit – Evaluate QMS compliance to ISO 13485, as well as other requirements of MDSAP-participating regulatory authorities.
- Surveillance audits – Surveillance audit is conducted annually to also assess any changes in the manufacturer’s products or QMS processes since the initial certification audit.
- Recertification audit – In the third year to evaluate a manufacturer’s QMS for its continued suitability and effectiveness in meeting QMS requirements under MDSAP.
Impartiality statement: As an ISO 17000 series accredited Certification Body, MDSAP Recognized Auditing Organization and a notified body subcontractor, we do not participate in the design, manufacture, installation or distribution of the products we certify nor do we participate in the design of quality management systems we certify and we do not provide consultancy services related to those products or services. In addition, UL does not certify quality management systems that have been designed by other companies in the UL family. We also do not link our certification activities to the activities of organizations that provide product or quality management consulting services. If you require such services please use an internet search engine to identify relevant providers.