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    P2.3 Qualify design and specs

    Home » P2.3 Qualify design and specs
     Breaking Down the Verification and Validation Processes for Medical Devices
    By MPE Team Member
    In Engineering, Medical Product Design
    Posted June 6, 2023

    Breaking Down the Verification and Validation Processes for Medical Devices

    Developing a medical device starts with identifying every user need your final product will meet. Then, those needs are translated into actionable product specifications. These are called design [...]

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     Traceability Matrix Template: Translate User Needs into Actionable Design Inputs
    By Andy Moulds
    In Downloads, Medical Product Design
    Posted January 27, 2023

    Traceability Matrix Template: Translate User Needs into Actionable Design Inputs

    A traceability matrix helps you define and track product requirements to reduce risk and carry initial insights through to realized products. Our template and traceability matrix explainer guide [...]

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     Whitepaper: How to Better Source User & Safety Needs for Your Device’s Traceability Matrix
    By Andy Moulds
    In Medical Product Design
    Posted October 27, 2021

    Whitepaper: How to Better Source User & Safety Needs for Your Device’s Traceability Matrix

    Creating a comprehensive traceability matrix hinges on sourcing accurate user, safety, science, and technology needs related to your medical device. Like most companies, your firm is probably [...]

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     Why Common Plastics Are Failing in Hospital Settings
    By Andy Moulds
    In Engineering, Medical Product Design
    Posted December 4, 2020

    Why Common Plastics Are Failing in Hospital Settings

    Patient safety and reducing hospital stays is the priority for healthcare institutions and one of the focus areas is preventing patients from getting HAIs (Healthcare-associated infections) [...]

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     How to Design and Produce Injection Molded Parts For Your Medical Device
    By David Giuntoli
    In Engineering, Medical Product Design
    Posted November 25, 2020

    How to Design and Produce Injection Molded Parts For Your Medical Device

    From toys and automotive parts to cell phones and mechanical components, injection molded parts can be found in many of the objects we interact with each day. In fact, it would be difficult to [...]

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     Designing the Right Medical Product Starts with Defining User Needs. Here’s How to Do it Right.
    By Andy Moulds
    In Design Strategy, Engineering, Medical Product Design
    Posted August 26, 2020

    Designing the Right Medical Product Starts with Defining User Needs. Here’s How to Do it Right.

    If you’re thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDA’s Design Controls. If [...]

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      These Are the Contents of a Proper Product Requirements Document
      August 8, 2023
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      Medical Device Development and Professional External Resourcing: How to Manage Product Development in Times of Economic Uncertainty
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    • 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
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    • 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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