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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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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Questions and resources to help you find the right medical device development partner for your unique needs and requirement.
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RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Learn if your device is RoHS 3 compliant.
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Medical device artificial intelligence (AI) overview of AI, applications and devices, investment landscape, and regulatory implications.
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Overview of battery safety for medical devices addressing design issues related to size, form, capacity and performance demands on batteries.
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Ingress protection for home healthcare medical devices covers the 60601-1-11 collateral standard and what developers should know.
