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    Monthly Archive for: "June, 2020"
    Home » Archives for June 2020
     Bridge the Gap Between User Needs & Unknown Design Inputs with Qualification Testing
    By Shane Fedon
    In Engineering, Medical Product Design
    Posted June 26, 2020

    Bridge the Gap Between User Needs & Unknown Design Inputs with Qualification Testing

    The first step in building a medical device is to identify the full range of user needs your product will meet. Only then can you begin actually designing a product by translating those needs [...]

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     Whitepaper: From Manufacturer to “Manufacturer of Record”: How to Evolve from an OEM to a Medical Device Brand
    By Chris Ross
    In Medical Product Design
    Posted June 19, 2020

    Whitepaper: From Manufacturer to “Manufacturer of Record”: How to Evolve from an OEM to a Medical Device Brand

    Original equipment manufacturers (OEMs) and contract manufacturers play an important role in the medical device industry. Whether they produce their own proprietary components or build entire [...]

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     Failsafe Your Medical Device Development Process with a Comprehensive Project Plan
    By Andy Moulds
    In Design Strategy, Engineering, Medical Product Design
    Posted June 9, 2020

    Failsafe Your Medical Device Development Process with a Comprehensive Project Plan

    The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps [...]

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    INSIGHTS
    • These Are the Contents of a Proper Product Requirements Document
      These Are the Contents of a Proper Product Requirements Document
      August 8, 2023
    • Medical Device Development and Professional External Resourcing: How to Manage Product Development in Times of Economic Uncertainty
      Medical Device Development and Professional External Resourcing: How to Manage Product Development in Times of Economic Uncertainty
      July 18, 2023
    • Your Medical Device’s User Interface Specification Is More Powerful Than You Think
      Your Medical Device’s User Interface Specification Is More Powerful Than You Think
      July 10, 2023
    • Risk Management Simplified: Streamline Your FDA Submission with a Hazard Analysis Worksheet
      Risk Management Simplified: Streamline Your FDA Submission with a Hazard Analysis Worksheet
      June 26, 2023
    • Does Your Medical Device Need Design Controls? Here’s What You Need to Know.
      Does Your Medical Device Need Design Controls? Here’s What You Need to Know.
      June 20, 2023
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