{"id":2110,"date":"2022-12-14T11:06:58","date_gmt":"2022-12-14T11:06:58","guid":{"rendered":"https:\/\/operonstrategist.com\/southafrica\/?page_id=2110"},"modified":"2024-08-08T04:09:04","modified_gmt":"2024-08-08T04:09:04","slug":"mdsap","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-za\/services\/turnkey-project-consultants\/mdsap\/","title":{"rendered":"MDSAP"},"content":{"rendered":"\t\t
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Medical Device Single Audit Program (MDSAP)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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What is MDSAP? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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MDSAP is a Medical Device Single Audit Program that allows the conduct of a single regulatory audit of a medical device manufacturer\u2019s QMS that satisfies various regulatory jurisdictions. This program was developed by a group of medical device regulators, the IMDRF, to allow the third-party auditors to conduct this single audit of medical device manufacturers which covers <\/span>ISO13485:2016<\/span><\/a> and respective regulatory requirements.<\/span>\u00a0<\/span><\/p>

MDSAP is a mechanism for producers of medical devices to have their compliance with the standards and laws of up to five distinct medical device markets, including Australia, Brazil, Canada, Japan, and the United States, audited once. The goal of MDSAP is to make it possible to conduct a single regulatory audit of a medical device manufacturer’s quality management system.<\/a><\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Looking For Medical Device Regulatory Consultants?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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