{"id":2547141,"date":"2023-06-12T08:56:00","date_gmt":"2023-06-12T12:56:00","guid":{"rendered":"https:\/\/platoai.gbaglobal.org\/platowire\/tips-for-a-successful-mdsap-audit-understanding-common-non-conformities-by-operon-strategist\/"},"modified":"2023-06-12T08:56:00","modified_gmt":"2023-06-12T12:56:00","slug":"tips-for-a-successful-mdsap-audit-understanding-common-non-conformities-by-operon-strategist","status":"publish","type":"platowire","link":"https:\/\/platoai.gbaglobal.org\/platowire\/tips-for-a-successful-mdsap-audit-understanding-common-non-conformities-by-operon-strategist\/","title":{"rendered":"\u201cTips for a Successful MDSAP Audit: Understanding Common Non-Conformities\u201d by Operon Strategist"},"content":{"rendered":"
<\/p>\n
The Medical Device Single Audit Program (MDSAP) is a regulatory program that allows medical device manufacturers to undergo a single audit that satisfies the requirements of multiple regulatory bodies, including the US FDA, Health Canada, and the regulatory bodies of Australia, Brazil, and Japan. The MDSAP audit is a comprehensive audit that covers all aspects of a medical device manufacturer’s quality management system (QMS), including design and development, production, distribution, and post-market surveillance. In this article, we will discuss some tips for a successful MDSAP audit and understanding common non-conformities.<\/p>\n
Tip #1: Understand the MDSAP Audit Process<\/p>\n
The first step in preparing for a successful MDSAP audit is to understand the audit process. The MDSAP audit is a comprehensive audit that covers all aspects of a medical device manufacturer’s QMS. The audit is conducted by an accredited third-party auditing organization (AO) that has been authorized by the regulatory bodies participating in the MDSAP program. The audit consists of three stages: Stage 1, Stage 2, and Stage 3.<\/p>\n
Stage 1: The Stage 1 audit is a document review that assesses the manufacturer’s QMS documentation to ensure that it meets the requirements of the MDSAP program.<\/p>\n
Stage 2: The Stage 2 audit is an on-site audit that assesses the manufacturer’s QMS implementation to ensure that it meets the requirements of the MDSAP program.<\/p>\n
Stage 3: The Stage 3 audit is a follow-up audit that assesses the manufacturer’s corrective actions to address any non-conformities identified during the Stage 2 audit.<\/p>\n
Tip #2: Identify Common Non-Conformities<\/p>\n
To prepare for a successful MDSAP audit, it is important to identify common non-conformities that are typically identified during the audit process. Some common non-conformities include:<\/p>\n
– Inadequate risk management processes<\/p>\n
– Inadequate design and development processes<\/p>\n
– Inadequate supplier management processes<\/p>\n
– Inadequate complaint handling processes<\/p>\n
– Inadequate corrective and preventive action (CAPA) processes<\/p>\n
By identifying these common non-conformities, manufacturers can take steps to address them before the audit and ensure that their QMS meets the requirements of the MDSAP program.<\/p>\n
Tip #3: Implement a Robust QMS<\/p>\n
To ensure a successful MDSAP audit, it is essential to implement a robust QMS that meets the requirements of the MDSAP program. A robust QMS should include:<\/p>\n
– A risk management process that identifies and mitigates risks associated with the design, development, production, distribution, and post-market surveillance of medical devices.<\/p>\n
– A design and development process that ensures that medical devices are designed and developed in accordance with applicable regulatory requirements and industry standards.<\/p>\n
– A supplier management process that ensures that suppliers are qualified and monitored to ensure that they meet the manufacturer’s requirements.<\/p>\n
– A complaint handling process that ensures that complaints are investigated, documented, and resolved in a timely manner.<\/p>\n
– A CAPA process that ensures that non-conformities are identified, investigated, and resolved in a timely manner.<\/p>\n
By implementing a robust QMS, manufacturers can ensure that their QMS meets the requirements of the MDSAP program and is prepared for a successful audit.<\/p>\n
In conclusion, preparing for a successful MDSAP audit requires an understanding of the audit process, identifying common non-conformities, and implementing a robust QMS. By following these tips, medical device manufacturers can ensure that their QMS meets the requirements of the MDSAP program and is prepared for a successful audit.<\/p>\n
The Medical Device Single Audit Program (MDSAP) is a regulatory program that allows medical device manufacturers to undergo a single audit that satisfies the requirements of multiple regulatory bodies, including the US FDA, Health Canada, and the regulatory bodies of Australia, Brazil, and Japan. The MDSAP audit is a comprehensive audit that covers all aspects […]<\/p>\n","protected":false},"author":2,"featured_media":2547142,"menu_order":0,"template":"Default","format":"standard","meta":[],"aiwire-tag":[5899,2141,933,3194,11,441,213,31242,132,18,9575,20,1388,526,679,3970,13352,5305,2890,368,956,8956,1164,29,219,1392,970,2174,2662,6129,2788,2336,2405,4217,2714,5852,591,154,4699,988,38,157,867,7132,7107,2921,1325,1745,6637,2799,11421,997,235,7190,379,6998,1216,743,6048,2671,50,31239,31240,1794,11317,4230,9099,1637,1031,5379,1424,603,7139,2083,747,2478,475,57,11348,749,389,58,10344,608,7140,60,61,7237,1041,541,3415,614,6010,660,8797,5522,1061,1249,396,7606,19553,255,7022,758,616,75,1674,5,10,7,31241,8,623,1754,548,402,828,299,831,490,23420,2680,2505,23179,23180,1100,1105,772,12479,3845,412,1111,705,7028,496,29032,416,2271,837,1856,4632,3309,778,710,11762,102,10403,16699,9554,3001,781,711,108,109,110,206,207,2437,1720,9605,5463,111,1468,2871,9929,514,428,642,916,31236,9,124,125,6],"aiwire":[23161],"_links":{"self":[{"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/platowire\/2547141"}],"collection":[{"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/platowire"}],"about":[{"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/types\/platowire"}],"author":[{"embeddable":true,"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/users\/2"}],"version-history":[{"count":0,"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/platowire\/2547141\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/media\/2547142"}],"wp:attachment":[{"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/media?parent=2547141"}],"wp:term":[{"taxonomy":"aiwire-tag","embeddable":true,"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/aiwire-tag?post=2547141"},{"taxonomy":"aiwire","embeddable":true,"href":"https:\/\/platoai.gbaglobal.org\/wp-json\/wp\/v2\/aiwire?post=2547141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}