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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A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...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...
Best Practices for Effective Medical Device Design Reviews - Featured Image

Best Practices for Effective Medical Device Design Reviews

Design Reviews are intended to be checkpoints during medical device product development to ensure th...
Top 10 Most Popular Greenlight Guru Posts of 2018 - Featured Image

Top 10 Most Popular Greenlight Guru Posts of 2018

Thank you for helping make 2018 another big and exciting year for Greenlight Guru!
6 Predictions for the Medical Device Industry in 2019 (and how you can prepare) - Featured Image

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

Within the past couple of years, we have experienced significant changes in the medical device indus...

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