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We can prepare your CIP, ensuring you will have a study designed to collect clinical evidence and safety and performance data.
- Coaching
- Consulting
Scientist / Quality Assurance Engineer
Fraunhofer Portugal AICOS
Porto, Portugal
I'm a QA Engineer at Fraunhofer AICOS. We help SMEs build better digital health solutions through prototyping, usability testing and human-centred design.
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We can prepare your CIP, ensuring you will have a study designed to collect clinical evidence and safety and performance data.
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We can prepare the Investigator’s Brochure of your medical device, ensuring the inclusion of all needed clinical and pre-clinical data.
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We can test your digital health solution for usability (efficacy, efficiency and satisfaction).
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We can assess your product and/or prototype regarding user experience (measuring engagement, acceptance, desirability or other aspects).
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We can help you with a usability assessment made by experts in usability, analysing it based on established guidelines.
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This course introduces user research, co-design, and evaluation methods, to enable participants to start learning about their users.
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This is a custom-built training series on User Research and Usability to help clients learn about their own clients or users.
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This course goes over the different methods for usability testing, metrics that you can be extracted, and how to use them as insights.
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Codesign and prototype training
In this course, you will learn the principles of co-design, and techniques on how to involve representative users in the design process.
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This course will teach you about the principles of inclusive design, why it is important, and how it might benefit your prototype/product.
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Investigator's Brochure training
We can provide your team with training on preparing the Investigator’s Brochure for medical devices, compliant with ISO 14155:2020.
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Clinical Investigation Plan training
We can provide your team with training on preparing the Clinical Research Plan for the clinical investigation of medical devices.