6 Pro Tips to Avoid MDSAP Non-Conformities
Medical device single audit program (MDSAP) streamlines the audit process for quality management system. MDSAP is a global initiative for a single regulatory audit of the QMS to meet multiple regulatory authorities’ requirements. The regulatory authorities...
MDSAP Surveillance Audits: What to Expect in Year 2 and 3?
Medical Device Single Audit Program (MDSAP) is a global initiative for single audit of QMS to satisfy multiple jurisdictions’ requirements. MDSAP covers the regulatory requirement of the U.S., Canada, Brazil, Japan, and Australia. Its purpose is to streamline...
How MDSAP Compliance Supports Faster Market Entry in Canada?
In Canada, Medical Device Single Audit Program (MDSAP) is a mandatory requirement for Class II, III, and IV medical devices. Only with MDSAP certificate can you apply for Medical Device Licence (MDL) for Class II, III, and IV medical devices. Health Canada accepts a...