{"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":"

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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