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Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market - Featured Image

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

Ultimate Guide to Agile Design and Development for Medical Devices - Featured Image

Ultimate Guide to Agile Design and Development for Medical Devices

                                Table of Contents   Overview - Agile Design and Development for Medi...
Design History File Ready Ideation: An Innovative Approach to Product Development - Featured Image

Design History File Ready Ideation: An Innovative Approach to Product Development

As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)?
10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist] - Featured Image

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

We distilled the insights from our research into this one guide + checklist that we hope will help a...
Integrating Human Factors into Design Controls to Improve Patient Outcomes - Featured Image

Integrating Human Factors into Design Controls to Improve Patient Outcomes

The relationship between human factors and design controls often creates confusion in the medical de...
Top 50 Medical Device Product Design and Development Companies - Featured Image

Top 50 Medical Device Product Design and Development Companies

Medical device companies have to overcome many significant challenges when bringing a new product to...
De Novo Pathway: Explaining the Process for Medical Device Companies - Featured Image

De Novo Pathway: Explaining the Process for Medical Device Companies

The De Novo pathway has been around for more than two decades, but it is still one of the least used...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

As medical device professionals, we share a common goal of producing safe and effective medical devi...
Abbreviated 510(k): Substantial Equivalence Through Performance Criteria - Featured Image

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...
Why Flexible Design Reviews Matter for Medical Device Product Development - Featured Image

Why Flexible Design Reviews Matter for Medical Device Product Development

It is my humble and expert opinion that the medical device industry has the most significant impact ...
How and When to Consider Human Factors - Featured Image

How and When to Consider Human Factors

When should you begin to consider human factors with your medical device design and development effo...
Medical Device Product Development Value Proposition - Featured Image

Medical Device Product Development Value Proposition

It doesn’t matter how long a company has been in business. Both startups and established companies n...

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