KURSUS
Mastering Compliance and regulation for Medical Device
Gain insight into how to ensure compliance for medical devices from early development to market removal. Learn EU MDR, FDA 21 CFR Part 820, ISO 13485 requirements – and how to apply them across the full product lifecycle.
Kursusdetaljer
København
21. september 2026
Varighed: 2 dage
11.000,00 - 12.000,00 kr.
Priser er ekskl. moms
Engelsk
Regulatory Compliance for Medical Devices: EU and US Requirements
You can build the best medical device in the world, but without the right documentation and the correct authorities’ approvals –you will not be able to sell your device to anyone within the EU and US.
This course gives you an overall introduction to the regulatory landscape for medical devices, focusing on compliance with ISO 13485, the EU Medical Device Regulation (MDR), and FDA 21 CFR Part 820.
You will learn what is required to obtain market approval in key regions—and what it takes to maintain compliance throughout the product lifecycle.
We will also explore how to manage changes to a medical device that has already been approved and is on the market, ensuring ongoing compliance in an evolving regulatory environment.
On the course you will work with
- Risk Management
- Design Controls
- Usability Engineering
- Clinical testing
- Classification of products
- Documentation
- Product approvals
- Change control requirements and processes
- Regulatory submission requirements for changes to marketed products
- Complaint handling and reporting to authorities including market actions
- FDA/ISO audits
- Supplier management
- Removing a product from the market
This course is for you if you work with medical devices and need EU/US compliance skills.
This course is relevant for participants working with MedTech products, including medical devices, in vitro diagnostics devices, and software.
The following groups will benefit from attending this course:
- Design Control specialists
- QC Specialists
- Manufacture Engineers
- New Product Introduction (NPI) Engineers
- Usability and Human Factors Specialists
- Project Managers
- Product Developers working with medical devices, including both physical products and software
- QA Specialists
- RA Specialists
- Clinical Specialists
- Technical Writers
Benefits for you as a participant
After completing the course, you will:
- understand compliance and expectations for medical devices
- know the terms, sequence of activities and processes in a medical device life cycle
- Have a full overview of life cycle management of a medical device
- Know the risks and consequences of “bad” development
- Know your stakeholders and their roles in a medical device life cycle
Benefits for your company
After completing the course, you will have an employee who:
- Understands the compliance and regulatory setup and expectations for medical devices
- Has knowledge on how development and manufacturing activities fits into common processes (e.g. risk management and change control)
- Can ensure smoother approvals and sustained compliance across markets
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Katharina Laungaard
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