Quality management systems for medical devices in an international environment
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
Australia: TGA (The Therapeutic Goods Administration).
Brazil: ANVISA (Agência Nacional de Vigilância Sanitária).
Canada: HC (Health Canada)
Japan: MHLW (Ministry of Health, Labour and Welfare) & PMDA (Pharmaceuticals and Medical Devices Agency)
United States of America: FDA (U.S. Food and Drug Administration and Center for Devices and Radiological Health)
What is the MDSAP certification process?
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.
After acceptance of the offer and before the actual audit, a gap assessment or project planning meeting may be useful to prepare the next steps in the process. A gap assessment provides a good opportunity to identify strengths and improvement potential of the quality management system in advance. A project planning meeting can be useful, especially for larger projects, to plan and coordinate schedules that involve auditing multiple sites.
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.