Usability Engineering
Efficient and Tailored Project Leadership
Understanding all users is crucial for developing effective medical devices. In-depth user research to understand the needs, preferences, and behaviours of all users.
Perdigó analyse the context in which these medical devices will be used. Understanding the different perspectives within healthcare: patients, hospitals, doctors and nurses, among others.
Integrated usability development
Ergonomics and a user-centred design approach are integrated to enhance the efficiency, safety, and comfort of use of medical devices, ensuring they are intuitive and minimise user error. The iterative design process allows for continuous incorporation of user feedback to refine and improve the product.
Comprehensive user-related risk analyses are conducted to identify and mitigate potential risks associated with device use. Compliance with MDR and IEC 62366 standards is ensured, providing full support for regulatory submissions.
Usability evaluation
Formative evaluations are conducted to gather early feedback on a device’s usability, ensuring thorough assessment throughout its development lifecycle.
Summative evaluation support ensures the device meets all usability requirements before market release, providing solid evidence of its safety and effectiveness.
Patient Information Design
The team of designers creates clear and effective patient information leaflets (PIL), instructions for use (IFU), and labelling to ensure users can safely and effectively operate the device.
Post-market usability and error studies
Post-market usability and error studies are supported to gather feedback from real-world use. This ongoing evaluation helps identify any emerging usability issues and informs future improvements, ensuring ongoing user satisfaction and safety.
