Quality Management of Medical Devices with ISO 13485 - Copenhagen
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IDA wants to make visible the link to the United Nations 17 Sustainable Development Goals (SDG). This event covers, among other things, the above development goals. Read more about the UN's 17 Sustainable Development Goals (SDG)
Master ISO 13485 quality management for medical devices. Gain insight into FDA's Quality System Regulation (21 CFR 820), ANSI/AAMI standards, IMDRF guidelines, and EU regulations. Stay ahead and ensure compliance with international requirements.
Comprehensive ISO 13485 Training: Practical Implementation & Global Compliance
This course provides a solid understanding of ISO 13485 requirements and how they can be effectively implemented in your organization. With a practical approach, it draws on real experiences from companies navigating the global market.
You'll gain the tools to navigate complex regulatory demands while maintaining high standards for patient safety. The training emphasizes agile implementation strategies tailored to global compliance challenges, making it especially relevant for STEM professionals working in regulated environments.
During the course, you will work on:- ISO 13485:2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes and the processes for EU harmonization and guidance
- Quality System Regulation 21CFR 820 and ANSI, AAMI, ISO 13485: Navigation of Regulatory Requirements
- Understanding international regulation and selected differences regarding IMDRF (& RAPS)
- ISO 14971:2019 Medical Devices — Application of Risk Management to Medical Devices (This publication was last reviewed and confirmed in 2025)
- ISO 19011:2018 Guidelines for Auditing Management Systems and an introduction to the MDSAP audit model
The course is for anyone wishing to master Quality Management for Medical Devices with ISO 13485
The Benefits for Your Organization:
The course is for you if you are a manager, startup founder, or key employee working with or planning to work with medical device quality systems.
This course is tailored for those seeking fundamental knowledge of quality management for medical devices in accordance with ISO 13485.
Benefits for youThis course gives you essential insights to ensure compliance, streamline processes, and build a strong foundation for regulatory success in an evolving industry.
After the course, you will:
- Understand of ISO 13485 quality management in relation to medical devices and global regulatory requirements
- Be able to apply ISO 14971 in risk management activities
- Gain insight into audit processes with ISO 19011:2018 guidelines and the MDSAP audit model
- Navigate the complexity of regulatory frameworks and documentation requirements with confidence, ensuring compliance in an evolving international landscape.
The Benefits for Your Organization:
After completing the course, you will have an employee who:
- Understands the regulatory requirements and expectations for medical devices
- Can contribute to risk management processes and regulatory documentation
- Has insight about audits processes and the MDSAP model
How the Course on Quality Management of Medical Devices with ISO 13485 is Conducted:
The course combines systematic review and ongoing discussion of ISO 13485 with interactive case work.
You will engage with real-life scenarios related to audits, global regulatory variation, and risk processes, and participate in group dialogue focused on best practices for implementation.
The Program Includes:Before the Course:
- Participants must complete a questionnaire with requests for specific topics to be explored in depth during the course.
During the Course:
- Two course days from 9:00 AM to 4:00 PM (breakfast from 8:30 AM)
- Full catering included
- Course materials provided
- Digital access to DS/EN ISO 13485:2016 standard
After the Course:
- Course certificate
InstructorJeanett Fleron
CEO, Fleron Consulting
- Expert in developing sustainable international business strategies, aligning companies, authorities, and organizations with European and global regulations and standards.
- Former strategic lead for international expert committees within medical devices and life sciences
- MSc (Social Sciences/Sociology), BSc (Nursing)
IDA supports the UN's world goals
IDA wants to make visible the link to the United Nations 17 Sustainable Development Goals (SDG). This event covers, among other things, the above development goals. Read more about the UN's 17 Sustainable Development Goals (SDG)
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