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P3.1 Validation (Transfer to mfg)

Home » P3.1 Validation (Transfer to mfg)
 9 Questions to Ask to Create a Foolproof Manufacturing Plan for Your Medical Device
By Andy Moulds
In Medical Product Design
Posted December 28, 2020

9 Questions to Ask to Create a Foolproof Manufacturing Plan for Your Medical Device

Nothing about launching a new medical device is simple. From the FDA’s regulatory requirements to usability testing, medical device development can seem downright byzantine. Unfortunately, the [...]

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 Reducing Risk of Medical Products Through Prototyping
By Ryan Held
In Human Factors & Usability Testing, Medical Product Design
Posted July 10, 2020

Reducing Risk of Medical Products Through Prototyping

Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a [...]

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 Human Factors and Usability Validation Report: Why You (& the FDA) Need a Good One
By Chris Ross
In Human Factors & Usability Testing, Medical Product Design
Posted March 13, 2019

Human Factors and Usability Validation Report: Why You (& the FDA) Need a Good One

The last thing a medical device manufacturer wants to receive in response to their FDA filing is a “request for additional information.” It’s usually not a deal killer, but at the very least it’s [...]

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 Balancing Market & Technology Product Needs by User Testing Early and Often
By Andy Moulds
In Human Factors & Usability Testing, Medical Product Design
Posted August 21, 2018

Balancing Market & Technology Product Needs by User Testing Early and Often

After months of allocating resources to your new product development project, it has moved into the validation process and user testing. There is the knock on your door and your team approaches [...]

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 How to use the FDA Process to Deliver a User-Friendly Medical Device
By Chris Ross
In Design Strategy, Medical Product Design, User Insights & Design Research
Posted January 24, 2018

How to use the FDA Process to Deliver a User-Friendly Medical Device

Seasoned medical device developers know that the FDA cares about safety and effectiveness, and nothing more. And because of the intense focus required to meet stated FDA expectations, it’s easy [...]

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Mindflow Design
ISO 13485:2016-Certified
ISO 9001:2015- Compliant

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.
INSIGHTS
  • Whitepaper: How to Leverage Your Medical Device Use Specification to Build a Better Product
    Whitepaper: How to Leverage Your Medical Device Use Specification to Build a Better Product
    January 7, 2021
  • 9 Questions to Ask to Create a Foolproof Manufacturing Plan for Your Medical Device
    9 Questions to Ask to Create a Foolproof Manufacturing Plan for Your Medical Device
    December 28, 2020
  • Medical Device Cleaning, Disinfection, and Sterilization 101
    Medical Device Cleaning, Disinfection, and Sterilization 101
    December 10, 2020
  • What is a Formative Usability Evaluation? (And Why Does Your Medical Device Need It?)
    What is a Formative Usability Evaluation? (And Why Does Your Medical Device Need It?)
    December 7, 2020
  • Why Common Plastics Are Failing in Hospital Settings
    Why Common Plastics Are Failing in Hospital Settings
    December 4, 2020
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Mindflow Design
2036 Corte Del Nogal Carlsbad, CA 92011
(760) 930-9285
mindflowdesign.com
CONTACT US TODAY
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