KURSUS
Usability Engineering for Medical Devices
Do you want to develop safe and compliant medical devices? Master the Usability Engineering process and meet the requirements of IEC 62366-1:2015/Amd 1:2020 as well as the FDA’s expectations.
4,8
/
5
Kursusdetaljer
København V
27. oktober 2026
Varighed: 2 dage
11.500,00 - 12.500,00 kr.
Priser er ekskl. moms
Engelsk
Usability Engineering and Regulatory Requirements for Medical Devices
When it comes to medical equipment, proper operation and usage can be a matter of life and death
Therefore, developing medical devices requires ensuring – and documenting – that the equipment is safe to use. It is thus a regulatory requirement to follow a ‘Usability Engineering Process’ during the development of medical devices and pharma products.
The requirements and expectations for this process are defined in IEC 62366-1:2015/Amd 1:2020 and the – FDA’s (US Food and Drug Administration) guidance Applying Human Factors and Usability Engineering to Medical Devices.
The FDA and Notified Bodies in Europe have increased their focus on usability engineering. They expect you to validate and document that your medical device is safe to use for its intended users, use(s) and use environment.
Why Focus on Usability Engineering?
It’s not enough for your medical device to have the right features if users are unable to use them correctly.
It is critical to consider human abilities and limitations in the interaction between the user and the medical device. Therefore, it is essential to evaluate your medical device’s user interface during the development process.
By integrating usability engineering during the development and risk management processes, you not only ensure compliance with regulatory requirements but also gain valuable insights during development. Ultimately, this leads to safer and more competitive products on the market.
Thus, there are several advantages to prioritizing usability engineering activities:
- Compliance with regulatory requirements
- Safe and effective use of medical devices
- Simple and intuitive user interfaces
- Reduced need for training and support
- Enhanced user experience
- Lower risk of liability claims and product recalls
- Fewer changes late in the development process can leading to a shorter time-to-market
- Increased market lifespan and customer loyalty
On this Course, You Will Learn How to Perform Usability Engineering for Medical Devices and Integrate the Activities into the Development Process.
You will be introduced to how you can systematically perform and document usability engineering activities that meet regulatory expectations and ensure a more usable medical device for your users and patients.
The course also provides a solid understanding of the relevant standards applicable to medical devices and usability (e.g., IEC 62366-1:2015/Amd 1:2020) and FDA’s expectations for human factors and usability information in medical devices.
The course is held in collaboration with Technolution, who are also responsible for the teaching.
This Course Is for You if You Work with MedTech or Phama Products
This course is relevant for participants working with MedTech products, including medical devices, in vitro diagnostics, combination products, and software.
The following groups will benefit from attending this course:
- Usability and Human Factors Specialists
- Project Managers
- Product Developers working with medical devices, including both physical products and software
- QA and RA Specialists
- Clinical Specialists
- Technical Writers
The course requires no prior experience with Usability Engineering but is also relevant for those who already have experience.
The benefits for you
After completing the course, you will have:
- An overview of usability engineering, requirements, and processes
- Knowledge of the usability engineering process concerning IEC 62366-1:2015/Amd 1:2020 and the FDA’s expectations
- Insights in how to report and document the medical devices usability engineering activities and results
- Practical experience applying usability engineering methods in your daily work
The benefits for your organization:
After completing the course, you will have an employer who:
- Understands the regulatory requirements and expectations for medical device Usability Engineering
- Can apply Usability Engineering methods in identifying use-related risks with your device
- Has knowledge how usability engineering fits into the development and Risk Management processes
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Katharina Laungaard
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