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Greenlight Guru Medical Device Blog

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Meet a Guru: Jesseca Lyons - Featured Image

Meet a Guru: Jesseca Lyons

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with...
How to Escape the Lure of Legacy Quality Management Systems - Featured Image

How to Escape the Lure of Legacy Quality Management Systems

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...
How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...
What is Regulatory Due Diligence for Medical Devices? - Featured Image

What is Regulatory Due Diligence for Medical Devices?

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...
22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles - Featured Image

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device qua...
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...
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...
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...
[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...
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...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...

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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