Medical Device Single Audit Program (MDSAP)

What is MDSAP?

MDSAP stands for Medical Device Single Audit Program. MDSAP is a program which allows a manufacture to receive a single audit to meet up to five regulatory quality system requirements at a single cost.  This single audit fulfills the requirements of many regulatory authorities. The audits are performed by Auditing Organizations (AO), which must be authorized by the Regulatory Authorities in order to audit for MDSAP. By having a single audit, a manufacturer can be audited once for compliance with the standard and any regulatory requirements, which includes ISO 13485.

Advantages and Disadvantages of MDSAP

There are many advantages of MDSAP. One of the main benefits of MDSAP is gaining access to multiple markets with a single audit. Having a single audit allows minimal disruptions within an organization; allowing the manufacturers and employees to be able to focus on their daily work rather than continuously prepare for numerous audits. In return, this allows internal supporting inspection staff to be able to focus on their tasks more, which reduces the impact that audits have on daily activities and schedules. Additionally, MDSAP ensures complete coverage of the requirements of all five participating regulatory authorities. Lastly, your organization will have routine audits schedules directly with the auditing organization. 

There are also several disadvantages of MDSAP. First, Regulatory bodies are allowed to conduct unannounced inspections based on issues they detected (including: recalls, vigilance issues or significant complaints), as well as special audits (i.e. if a manufacture is expanding its QMS scope).  In addition, if the audit has findings, the findings will be transmitted to regulatory bodies that the manufacturer selected for the audit. Some organizations have full time staff to help support inspections and audits. Today, the EU and some other markets require surprise audits, which becomes cumbersome and stressful.

In conclusion, the decision to contract for MDSAP audits most heavily relies on which markets the manufacturer targets. For example, a manufacturer operating only in the US market would see little or no advantage in contracting for an MDSAP audit, while a manufacturer selling into the Canadian market would be required to have MDSAP audits — the greater the number of MDSAP markets, the greater the advantage.

How to prepare for MDSAP

If your organization is getting ready to be audited it is advised to carefully go through any internal audits and look over every aspect of your QMS requirements. You should carefully look at any new requirements, and make sure that if you find any shortcomings within your QMS that these issues are fully addressed.

The IMDRF no longer maintains MDSAP. You should now familiarize yourself with the FDA website. The FDA includes materials such as procedures, forms, training material, regulatory information for participating countries, and contact information, as well as guidance on how to participate and prepare for an MDSAP audit.

Are all MDSAP standards met with ISO 13485:2016?

MDSAP requires that audits are conducted by AO. During the audit, these auditing bodies look to see if your company meets regulatory requirements, and although ISO 13485:2016 meets many requirements of MDSAP, it is your responsibility to ensure that your company meets any regulatory requirements as well.


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