Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
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The two key variables in rapid silicone prototyping are silicone material selection and moulding strategy.
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4 ways (with related principles) to make your medical device jig design process more effective. Jigs help us conduct tests and collect data.
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Adaptive studies can be especially useful in the pivotal stage if there are uncertainties about one or two aspects of the study.
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Review of sections 4, 5 and 6 of ISO 13485:2016 and the major changes from the 2003 version with potential impacts on QMS.
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FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing.
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Exploration of applying IEC-62366-1:2015 or human factors engineering to the design of medical devices compared to the FDA guidance document.
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The power of initial concept design sketches – It’s imperative they reflect all of the requirements, and not just the marketing ones.
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Medical device designers and developers need to address stress, fear, and embarrassment a patient might feel. as part of emotional design.
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The UX design process for medical device research places emphasis on safety and documentation using IEC 62366-1 and IEC 62366-2
