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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 ...
EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic - Featured Image

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies arou...
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...
Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies - Featured Image

Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies

Bundled offerings equip medical device manufacturers to better navigate regulatory pathways, bring d...
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem - Featured Image

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

What impact will the EU MDR changes have on the medical device ecosystem?
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...
How to Approach Verification and Validation for Cloud Software - Featured Image

How to Approach Verification and Validation for Cloud Software

Why is verification and validation (V&V) confusing and challenging for many medical device professio...
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...
What are the Changes to ISO 14971:2019 & TR 24971? - Featured Image

What are the Changes to ISO 14971:2019 & TR 24971?

Proper risk management is a key process throughout the entire life cycle of a medical device. This i...
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...

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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