Program Overview
This program provides a comprehensive understanding of the Medical Device Single Audit Program (MDSAP), its structure, and jurisdictional requirements across the US, Canada, Brazil, Japan, and Australia. Participants will learn how to align ISO 13485:2016 QMS with regulatory expectations, anticipate nonconformities, and prepare effectively for audit cycles. Through real-world case studies, interactive gap analyses, and role-play simulations, the course ensures professionals can develop robust readiness strategies that reduce compliance risks, streamline approvals, and enable faster market access.
Features
- Interpret MDSAP structure, audit model, and jurisdictional requirements.
- Map ISO 13485 clauses to global regulatory expectations.
- Identify and mitigate common nonconformities in MDSAP audits.
- Build a 90-day readiness roadmap for successful MDSAP implementation.
Target audiences
- Quality & Regulatory Affairs Managers
- Compliance & Audit Specialists
- R&D and Operations Teams in MedTech
- Project Managers
Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Foundations of MDSAP4
- 1.1Evolution of MDSAP: Regulatory rationale & global acceptance
- 1.2Participating authorities: FDA, Health Canada, ANVISA (Brazil), TGA (Australia), PMDA (Japan)
- 1.3Alignment with ISO 13485:2016 and GHTF principles
- 1.4Key Terms: Audit Model, Audit Task, Audit Companion Document, Jurisdictional Requirements.
- Audit Model & Jurisdictional Requirements6
- 2.1MDSAP audit structure: Chapters, tasks, linkages
- 2.2Country-specific nuances: FDA: 21 CFR Part 820 vs. ISO 13485
- 2.3Country-specific nuances: Health Canada: MDSAP as mandatory
- 2.4Country-specific nuances: PMDA/TGA: localized expectations
- 2.5Case discussion: How one company aligned global QMS with multiple regulators
- 2.6NC grading, MDSAP Audit Cycle, Country-Specific Addenda
- Practical Challenges & Case Insights5
- 3.1Common nonconformities raised in MDSAP audits
- 3.2Case studies: FDA finding vs. ISO 13485 compliance gap
- 3.3Case studies: Health Canada transition case during MDR migration
- 3.4Risk-based thinking: linking CAPA, internal audits, and management reviews
- 3.5Risk Priority, CAPA Effectiveness, Escalation Process, Supplier Controls
- MDSAP Readiness Challenge2
- Strategy & Wrap-Up3
Instructor
