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    P1.1: Consider and diagnose

    Home » P1.1: Consider and diagnose
     Essentials of a Medical Device Manufacturing Plan
    By MPE Team Member
    In Downloads, Medical Product Design
    Posted March 22, 2023

    Essentials of a Medical Device Manufacturing Plan

    This manufacturing guide outlines the most important information you need in your manufacturing plan to ensure timely project completion.

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     Your Guide to FDA Device Classification
    By MPE Team Member
    In Downloads, Medical Product Design
    Posted March 22, 2023

    Your Guide to FDA Device Classification

    Follow this one-page infographic guide to lead you to the proper FDA class for your medical device. If you don’t know which class your product falls into, you risk creating a development plan [...]

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     Competitive Technology Teardown – A Springboard to Meaningful Innovation
    By David Giuntoli
    In Medical Product Design
    Posted November 17, 2022

    Competitive Technology Teardown – A Springboard to Meaningful Innovation

    You're not tearing down to reverse engineer something but rather to spring toward innovation. Tearing it down will give you a great foundation of needed knowledge. Engineers tend to just worry [...]

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     4 Services to Meet Any Medical Device Development Challenge Head-On
    By Chris Ross
    In Medical Product Design
    Posted November 9, 2022

    4 Services to Meet Any Medical Device Development Challenge Head-On

    As you develop a medical device, there will be moments it becomes apparent you need outside assistance. No matter the crossroads you’re facing on your medical device design and development [...]

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     Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering
    By Elyse Hallett
    In Human Factors & Usability Testing, Medical Product Design
    Posted July 29, 2022

    Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering

    Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for [...]

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     Inside Access: How MPE (Formerly Mindflow Design) Fully Guides Your Device’s Development
    By Chris Ross
    In Design Strategy, Medical Product Design
    Posted December 14, 2021

    Inside Access: How MPE (Formerly Mindflow Design) Fully Guides Your Device’s Development

    It’s a consequential decision to hand over the responsibility of designing your medical device to an outside team — even if it’s only for part of the project. You need to have a lot of trust and [...]

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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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