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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In medical device development, verification is both a safeguard and a stress test, not just for the product, but for the process.
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In the world of medical device development, requirements are often treated as a regulatory tax, essentially documentation created solely to satisfy a compliance need.
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Most sterile medical devices begin their journey long before anyone thinks about sterilization. Teams focus on function, usability, materials, and suppliers, then discover that sterilization constraints can reshape many of those early decisions.
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Systems-thinking must always be present in medical device development. Systems Engineers (SEs) live where complex development needs managing. In a very small project team people can communicate continuously and tightly enough that everybody understands where they're headed and what's going on.