ISO 13485 is the internationally recognised quality management system standard specific to the medical device industry. Unlike general quality management frameworks, it is built around the regulatory and safety demands of medical device production — covering the full product lifecycle from design and development through to post-market activities. For organisations operating in the EU, certification to ISO 13485 provides the practical foundation for conformity assessment under EU MDR 2017/745 and a functioning, well-evidenced QMS is a prerequisite for market access across most regulated markets worldwide.
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What makes ISO 13485 demanding in practice is not the complexity of any single clause, but the coherence the standard expects across the entire system. Document control, risk-based thinking, design controls, supplier qualification and CAPA are not standalone requirements — they are interconnected and that connection is assessed closely during conformity assessment and surveillance audits. Organisations that treat the standard as a checklist tend to find gaps precisely where the system should be demonstrating integration. This training introduces the full structure and requirements of ISO 13485:2016 with direct reference to how those requirements are interpreted in current audit practice and what the forthcoming revision of the standard is expected to bring.
Key Topics Covered:
· Foundations of ISO 13485:2016: purpose, scope and relationship to EU MDR
· Core QMS requirements: document control, management responsibility, resource management and risk-based thinking at the system level
· Product realization: design and development controls, supplier qualification, process validation and traceability
· Measurement, analysis and improvement: internal audits, non-conformance management, CAPA and management review
· Audit readiness: the clauses most consistently cited in major findings and what well-prepared organisations do differently
· The forthcoming ISO 13485 revision: expected changes, alignment with ISO 9001:2026 and when to start preparing
Benefits:
- A solid understanding of ISO 13485:2016 requirements and how they apply across the full quality management system
- The ability to connect the standard's requirements to EU MDR and the obligations in day-to-day practice
- A clear picture of the forthcoming ISO 13485 revision and what it will mean for their organisation's QMS
- The ability to identify gaps between current QMS practice and the expectations of ISO 13485 certification
- Confidence in identifying gaps between current QMS practice and the expectations of ISO 13485 certification
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Target Audience: Quality Assurance and Quality Management Professionals, Regulatory Affairs Specialists, Product Development and Design Assurance Engineers, Production and Operations Teams, Supply Chain and Procurement Managers and Senior Leaders with accountability for the QMS.
Trainer: Irenej Polacek
Auditors
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Irenej Polacek
Moderator
Technica file reviewer / Auditor
A graduate biomedical engineer specialising in prosthetics, orthotics, orthopaedics, and custom-made cranio-maxillo-facial implants, he worked at CEIT Biomedical Engineering during his PhD. He gained extensive experience in dental medical devices as a product specialist at FONA Dental, collaborating with the design team and end users. He then joined 3EC International, a Slovak notified body, where he spent four years as a technical file reviewer and lead auditor, completing training in MDR, risk management, usability, PMS, and external auditing. Later, at DQS, he earned certifications from their comprehensive MDR, ISO 13485, and MDSAP conformity assessment training.