MDSAP Qualified Auditor

After an extensive training, I passed the required exams and am now a qualified MDSAP auditor for DEKRA Certification BV. The first MDSAP audits have been performed.

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

• Therapeutic Goods Administration of Australia
• Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers