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How to Successfully Obtain MDSAP Certification

Updated: Feb 15


Medical Device Single Audit Program (MDSAP) is a regulatory program that allows medical device companies to undergo a single audit process to satisfy the regulatory requirements of five countries: Australia, Brazil, Canada, Japan, and the United States. MDSAP certification is becoming increasingly important for medical device companies as it streamlines the audit process and reduces the need for multiple audits by different regulatory bodies. In this article, we'll provide an overview of MDSAP certification and discuss some tips on how to successfully obtain it.

Medical Device Single Audit Program (MDSAP) is a regulatory program that allows medical device companies to undergo a single audit process to satisfy the regulatory requirements of five countries: Australia, Brazil, Canada, Japan, and the United States. MDSAP certification is becoming increasingly important for medical device companies as it streamlines the audit process and reduces the need for multiple audits by different regulatory bodies. In this article, we'll provide an overview of MDSAP certification and discuss some tips on how to successfully obtain it.


Overview of MDSAP certification

MDSAP certification is a comprehensive and internationally recognized regulatory program that allows medical device companies to undergo a single audit process to meet the regulatory requirements of multiple countries. The MDSAP program was established in 2012 by the International Medical Device Regulators Forum (IMDRF) and is managed by the Regulatory Authority Council (RAC). The goal of the MDSAP program is to reduce regulatory burden for medical device companies by creating a standardized audit process that meets the regulatory requirements of multiple countries.


To obtain MDSAP certification, medical device companies must undergo a comprehensive audit that covers the regulatory requirements of each participating country. The audit is conducted by an accredited third-party auditor and covers areas such as quality management systems, design and development, production and service controls, and regulatory compliance. Once the audit is completed, the medical device company will receive a MDSAP certificate that is recognized by the participating countries.


Tips for successfully obtaining MDSAP certification

Obtaining MDSAP certification can be a complex process, but with the right preparation and approach, it can be achieved successfully. Here are some tips to help you obtain MDSAP certification:


  1. Plan ahead: Before beginning the MDSAP certification process, it's important to plan ahead and ensure that all necessary resources and personnel are in place. This includes identifying a team to manage the certification process, ensuring that all necessary documentation is available, and setting realistic timelines and milestones.

  2. Conduct a gap analysis: A gap analysis is a comprehensive assessment of the current quality management system (QMS) and regulatory compliance status of a medical device company. Conducting a gap analysis can help identify areas where the company needs to improve to meet MDSAP requirements. Once the gap analysis is complete, the medical device company can develop an action plan to address any deficiencies.

  3. Implement a risk-based approach: MDSAP requires a risk-based approach to quality management. This means that medical device companies need to identify and assess risks associated with their products and processes, and develop a risk management plan to mitigate those risks. Implementing a risk-based approach to quality management can help ensure that the company is prepared for MDSAP certification.

  4. Train personnel: It's important to ensure that all personnel involved in the MDSAP certification process are trained and competent in the relevant quality management system requirements and regulatory compliance requirements. This includes providing training on risk management, design and development, production and service controls, and other areas covered by the MDSAP audit.

  5. Engage with an experienced MDSAP consultant: Engaging with an experienced MDSAP consultant can be a valuable resource for medical device companies seeking to obtain MDSAP certification. An experienced consultant can provide guidance on the MDSAP certification process, assist with documentation and audit preparation, and provide training and support to personnel.

In conclusion, MDSAP certification is becoming increasingly important for medical device companies seeking to streamline the regulatory audit process and reduce regulatory burden. With the right preparation and approach, medical device companies can successfully obtain MDSAP certification and ensure compliance with the regulatory requirements of multiple countries.


Contact  BioBoston Consulting today or visit our  website to learn more about how we can support your organization.


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