QMS Compliance & Regulatory Training

Service Description

What We Deliver Role-based training: leadership, QA/RA, design & development, manufacturing, supplier management, post-market Foundations & advanced topics: ISO 13485 clauses, ISO 14971 risk management, document control, CAPA, internal audits, PMS/PMCF, data integrity Regulatory alignment: EU MDR/IVDR, MDSAP task mapping, FDA QMSR / Part 11, Health Canada, TGA, ANVISA, PMDA Training Formats Executive Briefing (2–3 hrs) – Strategic obligations, metrics, resourcing Core QMS Workshop (1 day) – Clause-by-clause essentials + case studies Advanced/Focused (½–1 day) – CAPA, internal audits, risk, PMS / PSUR / PMCF Delivery: Live virtual or on-site Outcomes You Can Expect Clear understanding of regulatory requirements and audit expectations Improved process ownership and right-first-time documentation Stronger CAPA effectiveness and PMS signal management Audit-ready evidence mapped to ISO 13485 and MDSAP tasks Sample Modules (Accordion Section) Module 1 – ISO 13485 Core Clauses (4–8) Process interactions, documentation hierarchy, and risk integration Module 2 – Risk Management (ISO 14971) Lifecycle risk control and linkage with design / production Module 3 – Design & Development Controls Traceability, verification & validation, design transfer Module 4 – Production & Service Controls Process validation, environmental monitoring, supplier oversight Module 5 – Nonconformity & CAPA Effectiveness Root-cause analysis, effectiveness checks, trending Module 6 – Post-Market Surveillance & Vigilance Complaints, PSUR, PMCF, reporting to authorities Module 7 – Internal Audit Program Design Planning, execution, reporting, continual improvement Who Should Attend: Executives & Site Leaders • QA/RA Professionals • R&D • Manufacturing & Operations • Supplier Quality • Post-Market / Clinical • Document Control Included Materials: Slides & worksheets • Clause cross-references Optional Add-Ons Procedure refresh (SOP updates aligned to training) Mock audit & coaching (evidence sampling, readiness) Compliance Mapping (At a Glance) ISO 13485:2016: 4.1, 4.2, 5.6, 6.2, 7.x, 8.x MDSAP: Ch. 1–5 tasks with evidence mapping EU MDR/IVDR: QMS obligations, PMS / PMCF / vigilance / PSUR FDA QMSR: Aligned with ISO 13485; linkages to 21 CFR 820 / 803 / 806