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Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

The medical device industry has a lot of acronyms. 
How to Construct an Effective Regulatory Strategy - Featured Image

How to Construct an Effective Regulatory Strategy

What is a regulatory strategy? What are the components involved?
EUA 101: What is Emergency Use Authorization and How can my Device get Authorized? - Featured Image

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...
How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices - Featured Image

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...
510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies - Featured Image

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

What does the 510(k) process involve? How should medical device companies know if this is the right ...
How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends - Featured Image

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

Medical device companies are among the most important players in the world’s response to COVID-19.
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers - Featured Image

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for fr...
How Software Architecture Enables Faster Release of New Clinical Tests to the Market - Featured Image

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...
Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives - Featured Image

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

During the COVID-19 crisis, medical device companies are improving and saving the lives of healthcar...
Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know - Featured Image

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this r...
COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health - Featured Image

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spr...
[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD) - Featured Image

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

In this modern digital world, did you know that most medical devices are not connected to the Intern...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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