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How to Integrate Usability into your Medical Device - Featured Image

How to Integrate Usability into your Medical Device

Medical device usability is a critical, yet confusing component of medical device design, developmen...
4 Emerging Trends in 2020 Backed by Medical Device Industry Experts - Featured Image

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

Throughout 2020, the medical device industry will see significant changes take flight. Among the big...
[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...
Medical Device Companies - Top 100 in 2020 (Free Chart) - Featured Image

Medical Device Companies - Top 100 in 2020 (Free Chart)

Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...
Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
How to Leverage IEC 62304 to improve SaMD Development Processes - Featured Image

How to Leverage IEC 62304 to improve SaMD Development Processes

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...
What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process? - Featured Image

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...
Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities - Featured Image

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

Medical device quality management system (MDQMS) aligns with latest version of globally recognized r...
Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions - Featured Image

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

How a company chooses to establish and maintain their quality system has everything to do with their...
How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

FDA Form 483 Observations and Warning Letters - What’s the Difference? - Featured Image

FDA Form 483 Observations and Warning Letters - What’s the Difference?

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...

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

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