Based on ISO 13485:2016, MDSAP (Medical Device Single Audit Program) is an audit program that allows for a single regulatory audit of a medical device manufacturer´s quality management system to satisfy the requirements of multiple regulatory jurisdictions. Our Head of Quality Dr Dirk Hüber explains more about what the program involves, whether and when to join, and how to prepare for your audit below…
An MDSAP audit evaluates your company’s QMS, rather than your products. The five countries that currently participate in the MDSAP program are:
In these countries, an MDSAP certificate is an alternative way to support market approval, apart from in Canada, where the certificate is mandatory to achieve market approval for your product.
The objectives of the MDSAP are to:
The advantages for manufacturers include the following:
When making your decision on whether to join the MDSAP program, there are three key considerations to bear in mind:
Consequently, it is advantageous for almost all MedTech companies to participate in the program in order to benefit from less audits, a transparent audit approach, and aligned requirements between five key markets (including EU requirements to an extent).
If you are a start-up company it is important to time your application to join MDSAP efficiently. The best time to join is as you file for market approval in one of the participating countries. This way, the regulatory authority of that country does not need to assess your QMS themselves; instead, they will receive the MDSAP certificate and audit report.
Of course, when following this path, you should be well prepared and have a stable, well established QMS in place, to avoid the risk of failing the MDSAP audit. Even if you are a start-up, it is advisable for you to have a QMS certified according to ISO 13485:2016 rather early in your pathway. This will also help to avoid any unwanted surprises when you file your first product for the first market, as it will support your team by having any evidence ready in the expected form and of the necessary quality.
Whether you are a start-up or an established company, the following steps should be taken when you come to join the MDSAP program:
Our Quality team here at Congenius has the necessary knowledge to facilitate MDSAP related projects. Simply get in touch with us to find out how we can help with your MDSAP challenge.