SafetyCulture Summit 2020

Digital MDSAP Audit Checklists

Determine gaps in the manufacturer’s QMS, implement corrective actions and achieve MDSAP certification using a mobile app

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Published March 26th, 2020

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is a certification program for the Quality Management System (QMS) of manufacturers that wish to sell medical devices to the following MDSAP participating countries: USA, Australia, Japan, Brazil, and Canada.

Initiated by the International Medical Device Regulators Forum (IMDRF), MDSAP intends to create a consolidated process for maintaining the safety and quality of medical devices by manufacturers that meet QMS international standards (ISO 13485:2016) and comply with the requirements of Regulatory Authorities (RA) of participating countries.

What are MDSAP audit checklists?

MDSAP audit checklists are tools used by quality managers to determine if the manufacturer’s QMS meets the requirements of ISO 13485:2016 and that of Regulatory Authorities. MDSAP audit checklists help quality managers determine the readiness of medical device manufacturers for MDSAP certification by recognized third-party Auditing Organizations (AO).

This article briefly discusses (1) the steps in working towards MDSAP certification; (2) technology to help ensure that implemented QMS meets the requirements of ISO 13485:2016 and of RAs; and (3) free MDSAP audit checklists.

6 Steps to Prepare for MDSAP Certification

  1. Gain an understanding of the ISO 13485:2016 standard and the RA requirements of the country where you are to sell medical devices.
  2. Identify areas for improvement in the current QMS by performing a gap analysis or a readiness audit to ensure adherence to ISO 13485:2016 and other requirements.
  3. Conduct quality monitoring audits and maintain a record of results.
  4. Define your organization’s competencies and determine training requirements for MDSAP certification based on the audit results.
  5. Ensure competency needs are met and that all parties involved are kept in the loop.
  6. Partner with an Auditing Organization for MDSAP certification.

Technological Solution to the Challenges of MDSAP Certification

Working towards MDSAP certification can be costly and time-consuming, especially for manufacturers reliant on paper-based audits. Time spent on documentation of audits, reporting, and filing of records can be better spent working on gaps discovered and improving QMS to get certified for MDSAP. iAuditor, the world’s most powerful auditing app and software, can help manufacturers meet ISO 13485 and RA requirements and maintain the quality and safety of medical devices. Solve the challenges of MDSAP certification by doing the following:

Here is a collection of our carefully prepared MDSAP audit checklists you can browse and use as part of achieving MDSAP certification and ongoing compliance.


Erick Brent Francisco

SafetyCulture staff writer

As a staff writer for SafetyCulture, Erick is interested in learning and sharing how technology can improve work processes and workplace safety. Prior to SafetyCulture, Erick worked in logistics, banking and financial services, and retail.