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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Writing and implementing standard operating procedures (SOPs) for the manufacture of medical devices is required by ISO 13485, FDA, and other regulatory bodies. An SOP is a set of written instructions that documents a routine or repetitive activity that is followed by employees in an organization. The development and use of SOPs are integral parts of a successful quality system. They provide directions to perform a job properly and consistently to achieve predetermined specifications and quality end results. SOPs address all requirements to complete the job or process safely and effectively.
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Exploration of the potential in using Medical Device AI with tips on how to avoid pitfalls in AI implementation.
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Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.
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XYZs of Medical Device Vibration Testing shares the basics of vibration testing from equipment to key concepts and definitions.
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Tips and lessons learned on how to manage medtech stakeholder expectations gleaned from 25 years of medical device development.
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How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.
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Seven Medical Device Commercialization Polarities with tips on how to manage them throughout the development and commercialization process.
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Favorite medical device development information resources and tips for getting unstuck with a new question or challenge.
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Women in STEM at StarFish Medical reflect on how we can contribute to better balancing the representation of women within the STEM industry.
