The Top 4 Benefits of the MDSAP (Medical Device Single Audit Program)

benefits of the MDSAP Medical Device Single Audit Program

 

In this article, you will learn the benefits of the MDSAP (Medical Device Single Audit Program).

The MDSAP (Medical Device Single Audit Program) helps to:

  1. Promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority;
  2. Enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on the industry;
  3. Promote globally, in the longer term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices;
  4. Promote consistency, predictability, and transparency of regulatory programs by standardizing;
    •  the practices and procedures of participating regulators for the oversight of third-party auditing organizations, and
    •  the practices and procedures of participating third-party auditing organizations; and
    •  leverage, where appropriate, existing requirements and procedures for conformity assessment.

ADDITIONAL BENEFITS OF THE MDSAP FOR THE MANUFACTURER PARTICIPATING IN THE PROGRAM?

A single audit is used in lieu of multiple separate audits or inspections by participating in regulatory authorities or their representatives. Therefore, for many medical device manufacturers, the MDSAP reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities.

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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Quality procedures templates

Three (3) Options to Create Document Control Management DCM Procedures:

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REFERENCES:

For more information about the benefits of the MDSAP (Medical Device Single Audit Program), refer to:

httpss://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

httpss://www.fda.gov/media/90179/download

httpss://www.orielstat.com/blog/what-is-mdsap-certification/

httpss://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/

httpss://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-single-audit-program-mdsap  

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!