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P2.3 Qualify design and specs

Home » P2.3 Qualify design and specs
 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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 Breaking Down the Verification and Validation Processes for Medical Devices
By David Giuntoli
In Engineering, Medical Product Design
Posted August 23, 2021

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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 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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MindFlow Design is a leading medical product development firm for Medical, Life Sciences, and Consumer Health Companies and is based in Carlsbad, CA. We aspire to introduce powerful, intuitive healthcare technologies to the world.
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  • Essentials of a Medical Device Manufacturing Plan
    Essentials of a Medical Device Manufacturing Plan
    March 22, 2023
  • The Only Human Factors Planning Guide You Need
    The Only Human Factors Planning Guide You Need
    March 22, 2023
  • Your Guide to FDA Device Classification
    Your Guide to FDA Device Classification
    March 22, 2023
  • Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
    Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
    February 20, 2023
  • Medical Device Developers: Give IFUs and Information Design Details Their Proper Due
    Medical Device Developers: Give IFUs and Information Design Details Their Proper Due
    February 15, 2023
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