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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Key variables in rapid silicone prototyping are material selection and silicone moulding strategy. Approaches and key points for mould design.
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Five points to consider. from the dot-com era to make our medical device digital health strategy bubble proof.
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Value-based care ‘shifts’ the medical healthcare industry from a ‘volume’ payment model to an ‘outcome’ payment model.
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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.
