Medical Device Single Audit Program (MDSAP)

PRNS provides MDSAP (Medical Device Single Audit Program) audit readiness, pre audit, Gap Audit.

MDSAP is a program that consolidates regulatory inspections across the globe. By complying with a comprehensive cycle of audits under MDSAP, a company can meet the regulatory requirements of multiple countries and jurisdictions. These jurisdictions currently are:

1. The United States Food and Drug Administration
2. Japan’s Ministry of Health, Labour and Welfare
3. Brazil’s Health Regulatory Agency (ANVISA)
4. Australia’s Therapeutic Goods Administration
5. Canada’s Health Canada