The Top 4 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.

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.

SUBSCRIBE AND FOLLOW US TO LEARN MORE.

For more details about the benefits of the MDSAP, follow us.

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

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You Formal Training about the benefits of the MDSAP.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

Get in compliance today, CONTACT US (Hablamos Español)

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