CERTIFICATION

MDSAP

Medical Device Single Audit Program

MDSAP allows a recognized auditing organization to conduct a single audit of a medical device manufacturer’s quality management system against applicable requirements of participating regulatory authorities. The certificate displayed on this page applies only to the named organization, listed sites and stated scope. Covered jurisdictions should be confirmed from the certificate and supporting documentation. MDSAP certification does not by itself grant product approval, clearance or authorization for sale. Requirements for a specific model, intended use, labeling and destination market must be assessed separately.

Need the Full Compliance Dossier?

Request the complete MDSAP certificate package, scope of registration and supporting test reports for your market entry review.

Request Documents

← Back to all certifications