MDSAP Auditor Training CertificationI with QMII

The Medical Device Single Audit Program (MDSAP) is a global audit framework that assists in the assessment of conformance to ISO 13485:2016 and appropriate national regulatory requirements. With QMII’s MDSAP Auditor Training, you can become certified as an auditing professional to assess compliance with the MDSAP framework. This blog post will delve into the importance of MDSAP Auditor Training Certification from QMII and why it is such an important certification for medical device manufacturers. We’ll also explore the benefits of becoming certified, and how you can go about getting certified yourself. Read on to learn more!

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is an international program that streamlines the process of audits for medical device manufacturers. The program allows a designated Auditing Organization (AO) to perform a single audit that satisfies the requirements of multiple regulatory jurisdictions.

MDSAP was developed in response to the growing trend of globalization in the medical device industry. As more and more companies look to expand their reach into new markets, the MDSAP program provides a way to simplify the process and reduce the costs associated with meeting multiple regulatory requirements.

The program is voluntary, but many countries have recognized MDSAP as an acceptable alternative to their own national audits. To date, the following jurisdictions have accepted MDSAP: Australia, Brazil, Canada, Japan, and the United States.

If you are a medical device manufacturer looking to expand your business into new markets, MDSAP could be a good option for you. QMII can provide training and certification for auditors who wish to participate in the program.

What is an MDSAP Auditor?

An MDSAP auditor is a professional who has been trained and certified to audit medical device companies that are seeking to comply with the requirements of the Medical Device Single Audit Program (MDSAP). The MDSAP is a program developed by the International Medical Device Regulators Forum (IMDRF) that harmonizes the requirements of multiple medical device regulatory authorities into one comprehensive audit.

MDSAP auditors must have experience in both quality management systems (QMS) and medical device regulations. In addition, they must be able to demonstrate their competence through a combination of education, training, and experience. Once certified, MDSAP auditors can perform audits at medical device companies around the world.

The MDSAP was developed to make it easier for manufacturers to comply with the requirements of multiple regulatory authorities. By harmonizing the requirements into one comprehensive audit, manufacturers can save time and money. In addition, because MDSAP audits are conducted by independent third-party auditors, they provide an objective assessment of a company’s compliance with regulatory requirements.

Who Needs to be Certified?

There are a few different types of certification available for MDSAP auditors. The most common and widely recognized is the QMII certification. There are also a few other lesser known certifications, but they are not nearly as common or respected. In order to be a certified MDSAP auditor, you must have completed a certain amount of training and have passed an exam. The QMII certification is the most popular and widely respected, so it is the one we recommend getting.

The Benefits of Certification

There are many benefits to certification, including:

-Improved quality of care for patients
-Reduced medical errors
-Increased patient safety
-Improved communication among healthcare professionals
-Better coordination of care
-Improved patient outcomes

The Process of Certification

The certification process for MDSAP auditors is a multi-step process that begins with the completion of an accredited training program. Once the training program is complete, candidates must then pass an examination administered by QMII.

After successfully passing the examination, candidates will be required to submit a portfolio of evidence to QMII for review. The portfolio must demonstrate the candidate's knowledge and understanding of the MDSAP requirements and how they relate to ISO 13485.

Once the portfolio has been reviewed and approved, candidates will be issued a certificate of competence from QMII. This certificate is valid for three years and must be renewed every three years in order to maintain active status as an MDSAP auditor.

Where to Get Trained

There are a few different ways that you can go about getting trained to become an MDSAP auditor. One option is to take a course through an accredited provider, such as QMII. This will give you the necessary knowledge and skills to perform audits according to the MDSAP requirements.

Another option is to get on-the-job training through working with an experienced MDSAP auditor. This can be done by shadowing an auditor during an audit or by participating in audit-related activities, such as review and analysis of documents and data.

Which route you take will depend on your personal preference and learning style. Whichever path you choose, make sure that you are fully prepared before beginning your career as an MDSAP auditor.


In conclusion, it is clear that MDSAP auditor training certification with QMII provides a comprehensive and robust learning platform which ensures companies have the necessary skills to develop industry best practices. By taking this course you will be able to understand the complex regulatory requirements in different countries and acquire an internationally recognized certification. With the right knowledge and understanding of the process, you will be well positioned to provide your clients with high-quality audit services that meet all international standards.