Aidence has obtained the Medical Device Single Audit Program (MDSAP) certificate after a successful audit of its Quality Management System (QMS). The programme fast-tracks the regulatory process for five major countries: the US, Canada, Japan, Australia, and Brazil. Aidence’s initial scope includes the US, Canada, and Australia.
MDSAP aims to manage a single audit of the QMS rather than multiple audits for each of the participating countries. For instance, the US Food and Drug Administration (FDA), which regulates the sale of medical devices, accepts the MDSAP audit report as a substitute for routine inspections.
Leon Doorn, Head of Regulatory Affairs at Aidence, said:
“The MDSAP certification is yet another milestone in our journey to have a global market entry of our AI medical solution.
Aidence’s quality management system already meets the requirements of ISO 13485. MDSAP extends these standards to locally applicable legal provisions, reflecting our continuous commitment to quality, safety, and compliance. ”
Our AI medical device, Veye Lung Nodules, is CE certified and used in over 70 sites across Europe, both in routine practice and lung cancer screening. Veye’s FDA 510(k) clearance is currently pending.
For more on our regulatory milestones, visit the Compliance page.