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The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2003 and their respective regulatory requirements. The agencies are working to update the requirements to the new ISO 13485:2016 standard.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
The FDA along with Therapeutic Goods Administration of Australia, Brazil's Agéncia Nacional de Vigilância Sanitária, Health Canada, Japan's Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) will be participating in a MDSAP Pilot. The FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections. MDSAP audit will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
Omnex specializes in implementing MDSAP programs that integrate ISO 13485 along with multiple regulatory requirements of agencies worldwide. Contact us for more information on how Omnex can help your organization.