COURSE
Quality Management of Medical Devices with ISO 13485
Gain a practical understanding of ISO 13485 and learn how to build and maintain a compliant quality management system for medical devices across the entire product lifecycle.
3,0
/
5
Course details
København
1 December 2026
Duration: 2 days
DKK 11,500.00 - 12,500.00
Prices are excluding VAT.
English
Course description
ISO 13485 is the key standard for quality management in the medical device industry and a prerequisite for developing, manufacturing, and marketing compliant products. In this course, you will gain a solid understanding of how the standard works in practice and how it supports both regulatory compliance and business performance.
The course combines a structured walkthrough of ISO 13485 requirements with practical examples, enabling you to translate the standard into operational processes in your own organization. You will learn how an effective quality management system supports both compliance and continuous improvement across the product lifecycle.
What you will work with during the course
- Structure and implementation of a Quality Management System (QMS) according to ISO 13485
- Design control and traceability in medical device development
- Quality in production and process control
- Supplier management and quality across the value chain
- Post-market surveillance and continuous improvement
- Audits, documentation, and regulatory compliance
Who should attend
This course is relevant for professionals working with quality assurance, development, production, or regulatory affairs in the medical device industry – or for anyone seeking a practical understanding of ISO 13485 in a regulated environment.
Your benefits
- Understand the requirements of ISO 13485 and how to apply them in practice
- Contribute to the development and maintenance of a compliant QMS
- Gain insight into the full product lifecycle from development to post-market activities
- Be better equipped for audits and regulatory inspections
- Translate standard requirements into practical improvements in your organization
Benefits for your organization
Your organization will gain a professional capable of working systematically with quality and ensuring compliance with ISO 13485. This supports robust processes, reduces risk, and strengthens the organization’s ability to bring safe and compliant products to market.
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