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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With the release of ISO 14644-5:2025, Cleanrooms and associated controlled environments, Part 5: Operations, the standard places increased emphasis on operational discipline, human factors, and contamination control behaviour.
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This article outlines the core elements of the PCCP framework, the types of modifications it applies to, and how the FDA expects manufacturers to use it in practice.
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In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik explore what sits beneath that progress, focusing on how these therapies are delivered and why delivery remains one of the hardest problems to solve.
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Ariana Wilson and Mark Drlik break down medical vs wellness devices and explain why two products with identical hardware can fall into completely different regulatory categories.
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Understanding how clinical ventilator development differs from commercial ventilator design is essential for teams planning early studies.
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Consumer health prediction shapes more of daily life than most people realize. In this episode of Bio Break, Nick and Nigel explore how retail data can reveal health information without a person ever speaking to a clinician.
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When reviewing evidence for a medical device, a single citation can shape an entire submission. In this Bio Break episode, Nick shares a biofilm referencing lesson that has stayed with him since the early 2000s.
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Every phase of a device’s life cycle involves different people with distinct needs—from clinicians and patients to service technicians and regulatory bodies.
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Ariana Wilson and Mark Drlik explore how teams can reduce the device development timeline without compromising quality or compliance.
