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  Look Before you Lead: Planning for Summative / Human Factors Validation Testing

  Areas to be considered in Summative / Human Factors Validation planning, include test environment, and user profile review.

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  5 Reasons Human Factors remain important in MedTech despite Artificial Intelligence

  5 reasons Human Factors remain important in medtech despite technological advancements like Artificial Intelligence (AI).

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  Avoid Common Medical Device Regulatory and QMS Hidden Costs

  Medical device regulatory and QMS hidden costs can often be avoided when projects are well defined early to understand and know the costs up front.

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  FDA’s Draft Guidance on Decentralized Clinical Trials: Analysis

  Analysis of FDA draft guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.”

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  4 Company Values To Guide Medical Device Development

  Company values that StarFish employees use most to develop better medical devices include looking deeper, cutting to the chase and getting better.

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  Unpacking the Potential of 6 Medtech Trends

  Medtech trends including AI, UX Design, Device Connectivity, and Sterilization Protocols that might impact your medical device project.

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  Incoherent-Light Hazard Classification for Medical Devices

  Commonalities and points of potential confusion of the “big 4” incoherent-light hazard classification and standards for medical devices.

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  Important Considerations when Designing Labels for Medical Devices

  Considerations for designing UDI labels for medical devices include ANSI/ISO Parameter Values, label verification and durability.

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  Strategies to Maximize Outcomes During Pre-Submission Meetings

  Strategies to maximize outcomes for interactions during regulatory pre-submission meetings using 4 simple, but effective steps.

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