Spotlight MDSAP: one audit for all requirements
The Medical Device Single Audit Program (MDSAP) is an international cooperation of different regulatory authorities in the US, Canada, Australia, Japan and Brasil with the objective to harmonize regulatory requirements for medical devices worldwide. Using a common standard for regulatory quality management audits, the regulatory approval requirements of individual regulatory authorities can thus be covered by a single audit.
This simplifies market entrance for manufacturers of medical devices in the member states.
Just recently, our colleagues from DQS Inc. in the USA completed their first MDSAP audit. The customer was well-prepared for this audit and so able to successfully demonstrate compliance with the requirements of the certification program.
We are particularly glad to report that this witness audit resulted in more US auditors for the Medical Device Single Audit Program assigned to DQS Inc., putting our US colleagues is in the same excellent position to win and process new customers for MDSAP as the offices in India and Australia have done already – with more offices following soon.
We look forward to continuing our excellent cooperation and wish our colleagues continued success.
Within DQS Group, DQS Medizinprodukte GmbH is the Recognized MDSAP Auditing Organization.
Director International Business Development at DQS Medizinprodukte
For more info and to receive an offer, please visit: https://www.dqs-med.de/en/our-services/system-certifications/mdsap/