Medical Device Single Audit Program – How Should You Prepare?


Are You Ready for the Medical Device Single Audit Program?

Preparatory measure to keep you compliant

Currently, global medical device manufacturers must undergo audits of their quality management systems by regulators in the countries in which they sell their products – this means manufacturers are subject to multiple audits by numerous agencies each with their own scientific principles, jurisdictional requirements and processes. Regulatory inspections are rigorous, requiring the time and labor of many individuals within a company, prior to, during and for any follow up actions required by the regulatory agency. These audits are a burden on regulatory agencies as well, requiring extensive time and labor on behalf of inspection bodies to review quality operations across a firm’s different manufacturing locations. The Medical Device Single Audit Program is among us and it is important that you prepare to achieve compliance.

To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP) whereby recognized Auditing Organizations (AOs) conduct a single audit of a medical device manufacturer that satisfies the relevant requirements of various regulatory agencies.

“MDSAP allows a reduction in the number of audits conducted resulting in less business disruption. The MDSAP audit was well planned and the well-organized audit expectations allowed us to plan resources ahead of time. Additionally, qualified and competent auditing organizations conduct audits in a consistent manner. The transition from our previous audit cycle to the MDSAP audit program was easy due to the documents available on the MDSAP website. Definitely, more sites will be added to the MDSAP program in 2017 and 2018.”

While the Medical Device Single Audit Program (MDSAP) has the potential to save medical device manufacturers time, labor and money, these audits will be rigorous, covering quality management system requirements found in ISO 13485:2003; Brazilian Good Manufacturing Practices; the FDA’s Quality System Regulation (21 CFR Part 820); and additional requirements from all regulatory agencies participating in the program, including product design, registration, licensing and adverse event reporting.

In this article, we present an overview of the Medical Device Single Audit Program MDSAP, the factors driving this program, the impact on medical device manufacturers, and what manufacturers should do now to prepare for an MDSAP audit.

Medical Device Single Audit Program for Medical Device Manufacturers

The medical device market has become increasingly global, with device companies manufacturing and selling their products in multiple countries. As a result, manufacturers must comply with the diverse guidelines, rules, procedures and deadlines of various regulatory jurisdictions governing the markets in which they operate.

The IMDRF was established in 2011 as a forum to discuss future directions in medical device regulatory harmonization. Comprised of medical device regulators from around the world, the IMDRF’s aim is to accelerate international medical device regulatory harmonization and convergence.

One of the areas where the IMDRF sees value in global harmonization of diverse regulations is in the auditing and assessment of medical device manufacturing quality systems. The organization believes a unified approach to such audits may improve device safety and oversight on an international scale. With this in mind, the IMDRF established an MDSAP workgroup to develop a standard set of requirements for auditing the quality systems of medical device manufacturers’ that satisfies the requirements of multiple regulatory jurisdictions.

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