MDSAP Audit model is the combined conformance and compliance audit method for Medical Device Manufacturers. This integrated audit method is recognized by FIVE different jurisdictions such as Australia, Brazil, Canada, Japan and USA (FDA). Health Canada has made MDSAP certification mandatory to sell medical devices in Canada. Australia, Brazil, Japan and US FDA will accept MDSAP certification as substitute for initial or routine inspections for Medical Device compliance requirements.
European Union and several other countries are observing the possibilities for accepting MDSAP Audit as a viable certification instead of compliance inspections.
IMDRF, the developers of MDSAP is expecting to make MDSAP the Global combined Conformance and compliance Certification for Medical Device Manufacturers. The MDSAP audit criteria is ISO 13485:2016.
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