Request a quote
Your local point of contact
We will be happy to provide you with a customized offer for your MDSAP certification.
Harmonization of regulatory requirements
One procedure for up to fivefold market access
Broad acceptance of MDSAP audit reports
Plannable audit content
Less impact on operative business
In the first step, you discuss your company and the goals of an MDSAP certification with us. Based on these discussions, you will receive an individual offer tailored to the needs of your company or organization.
The assessment of your quality management system is performed in stages by means of a system analysis (stage 1) based on your QMS documentation and a subsequent on-site system assessment (stage 2), during which an experienced assessor evaluates the effectiveness of your processes for compliance with applicable requirements. The results are presented to you at a final meeting and summarized in an audit report. If the audit result is positive, the audit report includes the assessor's recommendation to issue the MDSAP certificate.
After the audit, the results are evaluated by the independent certification board of DQS Medizinprodukte GmbH (DQS MED). If all requirements are met, the assessor's certification recommendation is confirmed and you receive your MDSAP certificate.
Either semi-annually or annually, key components of the system are re-audited on-site for further improvements. The certificate expires after three years at the latest, but recertification is performed before expiration to ensure continued compliance.
If you are interested in certification based on the Medical Device Single Audit Program, you have come to the right place.
We are pleased that you are interested in our certification and assessment services. We would be happy to provide you with a free, no-obligation quote.
To do so, we need some information about your organization. Please fill in the basic MDSAP data and send it to us. You can find more information in the document "Explanation of basic data MDSAP".
All important information about the MDSAP program can be found compactly and clearly on our flyer.