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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Pre-Testing for ISO 18562-2:2017; how to approach in-house pre-testing and add confidence to 18562:2-2017 formal testing.
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Onsite or Virtual Audits uses an internal survey of QA/RA professionals to understand and weigh the pros and cons of virtual vs onsite audits.
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2021 Update on Health Canada's medical device regulatory development during the COVID-19 pandemic and lessons learned from the experience.
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Listening Strategy for Startups offers a three-pronged approach to stay competitive within the startup ecosystem.
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Explanation of changes in medical device symbols and practical implications as a result of the ISO 15223-1:2021 Symbols Update.
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Considerations when developing a diagnostic product that is intended for use outside a traditional laboratory.
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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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FDA Approved or Cleared Medical Device – the pathway you choose depends on the level of risk it represents and its intended use.
