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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Outlines how medical device designers can perform in-house Medical Device Drop Test per IEC 60601-1 before third party testing.
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The intent of this checklist is to aid self-assessment of your medical device commercialization readiness relating to regulatory requirements. Compare the answers you provide with stages from the StarFish Product Development Process at the end of the checklist to identify how ready you are for applicable regulatory requirements.
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The main success criteria for medical device companies after earning FDA regulatory clearance is securing positive coverage decisions from payers. While regulatory approval is sufficient to get a product to market, it has no bearing on product adoption. The availability of reimbursement has a direct impact on therapy adoption – it can “make or break” a product1. This primer provides an overview of US reimbursement codes and when they are used to help determine coverage and payment for medical devices.
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Designing BLDC motor drive electronics focuses on the particular strategy of driving the motor windings with sinusoidal waveforms.
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3D Printed Parts Streamline Development provides context for designers using 3D printed parts as a part of their market-ready medical devices.
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Optical Safety for Ophthalmic Instruments covers safety limits and maximum exposure limits of wavelengths in the IR, UV and visible light spectrum.
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Coupling light from LEDs and light guides in Medical Devices overview and tips include putting the light-guide entrance face as close as possible to the LED output face.
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Medical Device Design for the Developing World – why are there so many nonfunctional and broken medical devices in low-income regions?
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Simulated Fluids for POCT Development enable testing using a liquid that mimics the critical properties of the desired clinical sample.