MDSAP Lead Auditor: Why This Certification Is So Valuable in the Market

MDSAP lead auditor training develops the skills to plan, conduct and report audits of medical device quality management systems. The programme brings together requirements from Brazil, the United States, Canada, Australia and Japan.

Where training makes a difference

Internal auditors, consultants and quality managers need to connect ISO 13485:2016 to each jurisdiction's requirements, analyse evidence and identify nonconformities. These skills support the team's work and manufacturers' preparation for external audits.

A manufacturer's MDSAP certification is conducted by a recognised Auditing Organization. Completing a training course does not replace that process or the professional qualification criteria required by those organisations.

Current regulatory foundations

HSC's programme has been revised for MDSAP AU P0002.011, revised on 03/08/2026, and the legislation in force in the five jurisdictions. For Brazil, the Good Manufacturing Practice reference is RDC 665/2022; in the United States, the QMSR incorporates ISO 13485:2016 by reference into 21 CFR 820.

HSC's current MDSAP programme - 2026 edition

MDSAP Lead Auditor, Excellence & Strategic Leadership. A 42-hour programme updated for the 2026 MDSAP AU P0002.011, with Exemplar Global certification. The instructor is Mariana Barreira, an MDSAP lead auditor. HSC Global Group is a Recognized Training Provider (RTP) recognised by Exemplar Global.

The format is live online. Recorded Module 1 is a prerequisite for attending the live sessions; class recordings support enrolled students and remain available for 120 days after the programme ends. Teaching materials remain available for 1 year. Course handbooks, standards and exercises are included.

November cohorts

• Full-time: 09 to 13 November 2026, from 08:30 to 17:30.
• Evening: 17 November 2026 to 26 January 2027, from 19:00 to 22:30.
• 12 places planned per cohort; registration closes on 06 November 2026. Dates are subject to change, with cohort confirmation up to 5 days before the start.

Programme

• The lead auditor's mindset. Recorded, and a prerequisite for attending the live sessions.
• The Audit Approach task by task, through ISO 13485:2016.
• Jurisdictional requirements: Brazil, the United States, Canada, Australia and Japan.
• Grading nonconformities and the audit report.
• Audit planning, sampling and execution.
• Audit simulation and final assessment.

The total number of modules, fees and former student terms must be confirmed with the team. Individual modules and a wholly recorded course are not offered.

Certificate and terms

A minimum attendance of 75% and a minimum mark of 70% are required for the certificate. Cancellation with a full refund is available within 7 days of entering into the contract, under Article 49 of the Brazilian Consumer Protection Code.

The training certificate is not a manufacturer's MDSAP certification and does not, by itself, confer authorisation to conduct official audits. Auditors working for recognised organisations must meet those organisations' own competence criteria.

Explore the programme and request enrolment. Does your team conduct internal audits? Explore the MDSAP Internal Auditor programme, which covers ISO 13485:2016, the MDSAP Audit Approach and the changes in ISO 19011:2026. The Internal Auditor programme's duration, format, dates and fees must be confirmed with the team.

References

• MDSAP - FDA
• RDC 665/2022 - Anvisa