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With our quick guide, you can implement the usability process in compliance with IEC 62366-1, avoid costly rounds of revisions and pass the MDR and FDA audit with confidence.
As a manufacturer of AI-based medical devices and IVDs, get an overview of the AI Act and the tasks ahead.
Learn how to use large language models (LLMs) specifically in the development of medical devices – from the initial idea to post-market surveillance.
This article explains what manufacturers and laboratories need to know to avoid problems and unnecessary expense.
What sets us apart: We offer more than just advice—we are your reliable partner from the initial analysis to successful implementation. Our interdisciplinary team of lawyers, compliance experts, and process consultants works hand in hand to provide you with comprehensive solutions. We rely on proven methods combined with innovative approaches. From risk analysis and strategy development to implementation and ongoing monitoring – we provide everything from a single source. The result: legally compliant processes, reduced compliance risks, and more time for what really matters – your company's growth.
Get an overview of all the necessary regulations and standards so that you can quickly and safely get your medical and IVD medical device approved in the EU market.
"The Johner Institute’s usability team provided us with excellent support during the summative usability testing of our medical device – from the structured recruitment of participants and the precise drafting of the trial plan right through to the final report. We were particularly impressed by their flexibility, their quick response times to feedback and their proactive communication of preliminary results. Thanks to their professional, accommodating manner and their technical expertise, we were able to complete this critical step in the approval process with confidence."
Barbara Suter | Customer Experience & Solution Design | Roche
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