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  When Tolerance Studies Add Value in Medical Device Development

  Examples of how to apply tolerance studies that add value to medical device design and ultimately to biomedical start-ups.

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  Reducing Costs in Medical Device Verification and Validation

  How to identify hidden costs in medical device Verification & Validation along with mitigation measures to reduce the expense. 

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  Tips to Avoid Medical Device AI Pitfalls

  Exploration of the potential in using Medical Device AI with tips on how to avoid pitfalls in AI implementation.

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  Preparing EUA Medical Devices for Post-Pandemic Use

  Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.

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  Regulatory Science Tools Reduce Risk in New Medical Devices

  How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.

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  Integrating Microfluidics into Biomanufacturing

  Integrating Microfluidics into Biomanufacturing overview and top 4 enabling features of microfluidics for biomanufacturing.

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  Medical Device NPI & Commercialization Lessons Learned

  Medical Device New Product Introduction (NPI) & Commercialization lessons for medical device strategy, design, development, and NPI success.

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  How to Perform Medical Device Drop Test

  Outlines how medical device designers can perform in-house Medical Device Drop Test per IEC 60601-1 before third party testing.

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  Regulatory Checklist

  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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