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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Medical device startups/founders and enterprise partners have unique strengths and goals, which are often reflected in the way they work with CDMO (Contract Development and Manufacturing Organizations) partners.
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In the highly regulated world of medical device development, ensuring product safety, quality, and compliance is essential. One critical yet often overlooked aspect of this process is test method validation (TMV) in medical device development.
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A structured, well-documented design review process is a critical component of successful product development, particularly in the medical device industry.
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In medical device development, we deal with complex projects that span multiple disciplines, timelines, and regulatory gates. It’s a constant balance between moving fast enough to innovate, but slow enough to stay compliant.
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Ariana and Mark walk through FDA-approved options and explain how to select the right one for your product. From metals to plastics and electronics, not all devices can handle the same process.
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Many clients now request their devices to look and feel like Apple products. But achieving that level of simplicity and elegance is not as easy as it seems.
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How can you and your company culture thrive in collaboration with a MedTech CDMO? Learn the eight client traits CDMO teams say are key to building strong, successful partnerships.
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Ariana Wilson and Mark Drlik dive into how the FDA is adopting artificial intelligence to modernize its regulatory processes. With a new chief AI officer in place and rumors of collaboration with OpenAI, the agency is taking major steps to automate review workflows and improve efficiency.
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Nick and Joris break down what a DHF is, why it's required, and how it plays a vital role throughout the development lifecycle.
