Usability of Medical Devices according to IEC 62366-1
Reduce the risk of application errors with usable Medical Devices
and increase safety and performance for patients and users.
The application of Usability to Medical Devices is closely linked to risk management and deeply rooted in the fundamental safety and performance requirements of the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). The FDA also places requirements on what it calls "human factors engineering".
Usability aims to reduce the risks caused by application errors as far as possible by taking into account, for example, the technical knowledge, experience and training, and further education of users.
IEC 62366-1 can be used to fulfill the regulatory requirements. This standard describes the requirements for a Usability oriented development process.
Frequently asked questions about the development of Medical Devices in terms of Usability - Sound familiar?
The product is completely developed and "all of a sudden" the Usability file has to be created?
- But how should we do this? Using which templates?
- How is it to be understood in the daily norm?
- With how many people do I have to carry out the Usability tests so that they are representative?
- Do I have to do the whole Risk Management again?
Do I really need this? My products are super safe and easy to use!
The Usability File
In the Usability file, all documents that prove that you meet the Usability requirements for Medical Devices from IEC 62366 and, if applicable, the FDA, are compiled. How you assemble the file is not specified, but it should at least include the following contents:
- Extended purpose
- The user
- The context of use and
- The user product interface
- Verification and validation documents
Usability engineering according to
IEC 62366-1 can be confusing - We can ease your confusion!
Regardless if you need help with new development or existing product we will show you how to compile your Usability file effectively and compliant. Our company will accompany you in any necessary tests for formative or summative evaluation.