Manufacturers of medical devices, IVD medical devices, and combination products must avoid delays in development and approval, lack of market success, and harm due to poor usability. The same applies to internal disagreements over design concepts.
This is exactly where our formative evaluations in all markets around the world help:
The secret of successful devices: User research and formative evaluations help manufacturers elicit user requirements and identify strengths, weaknesses, and risks in design concepts and prototypes, leading to targeted design improvements.
Through targeted evaluation methods and competent moderation, formative evaluations can ensure manufacturers have the insights they need to develop successful devices. Successful devices help users to complete tasks efficiently and offer a good user experience.
Formative evaluations are the prerequisite for legally compliant usability files, for fast and scheduled device approval, and for successful audits and reviews.
Our usability team will help you select the most suitable method for your task and your devices, such as
Contact us now to perform professional formative evaluations and ensure that your devices meet the expectations of your users and auditors.
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We help you create the prerequisites for the rapid approval of your devices with IEC 62366-1 and FDA compliant summative evaluations.
With our usability labs in Germany and the USA, you create all the prerequisites for successful usability studies and usability
We take over the complete recruitment of healthcare professionals for your usability studies – from search to support on the day of the test.
We help you prove your marketing claims quickly and credibly and thus boost the marketing of your devices.
Need a standard-compliant usability file (human factors engineering file) to pass audits and approvals? We have the know-how! Our customized templates and professional support make it possible.
We analyse and evaluate the usability of your medical devices in everyday use in accordance with MDR after they have been placed on the market.
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