Since medical devices are generally safety-critical, specific usability requirements are applicable. Therefore, usability is an important building block in the product development phase as well as its entire life cycle: manufacturers need to ensure patient and usability safety, efficient usage as well as user satisfaction during application. Manufacturers are responsible for the necessary implementation of a usability-oriented development process in order to comply with its due diligence for conformity assessment in accordance with EN 60601-1-6 (or EN 62366).
In order to simulate the typical usage circumstances, the following factors are required: a well-defined development process, qualified personnel and the essential user application environment. The so-called subject group tests can only be conducted by individuals who meet the target group description and are not contributors to the development. These tasks and tests can be outsourced to external companies, like BEO BERLIN®.
- File preparation in accordance with EN 60601-1-6 and/or EN 62366
- Work process description and integration into impacted processes
- Usability specification: written method-determination (product management)
- Typical usage scenario description (main and sub-cases)
- Coordination of possible verification and validation steps with the manufacturer
- Verification and validation step implementation
- Usability report
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