{"id":665,"date":"2023-06-01T16:05:39","date_gmt":"2023-06-01T16:05:39","guid":{"rendered":"http:\/\/148.76.139.49\/qci-global\/?page_id=665"},"modified":"2023-07-04T14:16:54","modified_gmt":"2023-07-04T14:16:54","slug":"medical-device-single-audit-program-mdsap","status":"publish","type":"page","link":"http:\/\/148.76.139.49\/qci-global\/medical-device-single-audit-program-mdsap\/","title":{"rendered":"Medical Device Single Audit Program (MDSAP)"},"content":{"rendered":"\n
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Medical Device Single Audit Program (MDSAP)<\/h1>\n

The Medical Device Single Audit Program (MDSAP) is designed and developed to cover relevant requirements from the Regulatory Authorities participating in the program.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n

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Today\u2019s environment is filled with intense scrutiny but being competitive means never standing still.<\/h2>\n

QCI Global helps you see a way forward so you can advance confidently.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n

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Meet Regulatory Requirements<\/h3>\n

Minimize business impacts through a single audit program in lieu of multiple separate audits by the participating regulatory authorities.<\/p>\n <\/div>\n

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Access New Markets<\/h3>\n

When certifying to the MDSAP, you enable regulatory access to sell your device in Australia, Brazil, Canada, Japan and the United States.<\/p>\n <\/div>\n

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Demonstrate Commitment to Quality<\/h3>\n

MDSAP provides a comprehensive quality management system focused on areas directly impacting safety, performance and reliability in the medical device lifecycle.<\/p>\n <\/div>\n

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Protect Consumer Safety<\/h3>\n

Embed a robust risk management framework throughout all processes in the medical device lifecycle to ensure consumers receive safe and reliable products.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n

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What Is It?<\/h2>\n

The MDSAP model allows recognized Auditing Organizations to conduct a single audit that satisfies compliance requirements and regulatory requirements of participating authorities. This means that the MDSAP audit report can substitute routine agency inspections.<\/p>\n

Ending its pilot phase and becoming fully implemented in January 2017, the Medical Device Single Audit Program (MDSAP) is an initiative of the Therapeutic Goods Administration of Australia (TGA), the Brazilian Ag\u00eancia Nacional de vigil\u00e2ncia sanit\u00e1ria (ANVISA), Health Canada (HC), United States Food and Drug Administration (FDA) and Japan\u2019s Ministry of Health Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).The implementation of MDSAP consists of three key stages, including the initial audit (stage 1 and 2), surveillance audits and recertification audit.<\/p>\n <\/div>\n <\/div>\n

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