Quality Management for Medical Device Manufacturers under MDR/IVDR and EN ISO 13485
Get your Quality Management System (QMS) into shape—lean, structured, and audit-ready. This training provides a practical, easy-to-follow introduction to EN ISO 13485 and shows how to translate the standard’s requirements into clear, workable processes and documentation that teams can use day to day. While ISO 13485 is the clear focus, we also point out selected EU MDR/IVDR QMS interfaces at a high level—so you understand where the Regulation expects procedures, responsibilities, and evidence to be embedded in your QMS.
The training can be delivered in-house (on-site) or in a dedicated customer session. Depending on your needs, the emphasis can be tailored—for example, stronger focus on supplier controls, production controls, nonconformities, CAPA effectiveness, documentation, or audit readiness.
Course Outline
- ISO 13485 foundations: structure, terminology, documentation expectations
- Document & record control: building lean, audit-ready documentation
- Leadership & governance: responsibilities, communication, management review
- Resource management: competence, training, infrastructure
- Supplier management & outsourced processes
- Production/service provision: controls, traceability, nonconformities
- Measurement & improvement: internal audits, CAPA, effectiveness
- EU MDR/IVDR QMS interfaces
Learning Outcomes
By the end of the course, participants will be able to:
- Explain the structure and intent of ISO 13485 and what auditors typically expect as objective evidence.
- Set up effective document & record control that supports compliance without creating unnecessary bureaucracy.
- Implement the core QMS processes that drive consistent execution and audit performance, including:
- Leadership responsibilities, roles, communication, and management review
- Resource management: competence, training, and infrastructure
- Supplier selection, evaluation, and control of outsourced processes
- Production/service controls, identification/traceability, and handling nonconforming product
- Internal audits, CAPA, effectiveness checks, and continual improvement
- Recognize a set of MDR-related QMS touchpoints (e.g., compliance strategy and change management, structured communication, vigilance reporting processes) as part of the manufacturer’s QMS expectations.
Who Should Attend
Ideal for professionals in:
- Quality Management
- Regulatory Affairs
- R&D/Engineering
- Operations/Production
- Purchasing
- Supply Chain
- Suppliers/subcontractors working with ISO 13485 expectations
Suitable as an introduction or a refresher—no prior QMS knowledge required.
Why You Should Attend
If you want training that is clear, practical, and immediately usable, this is it. You’ll leave with a strong understanding of ISO 13485 and a straightforward approach to building a QMS that supports your business—not just the next audit.
NSF contributes to global standardization through participation in ISO/TC 210/WG1 ("Application of quality systems to medical devices"), bringing insight into the intent behind QMS requirements.
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