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Greenlight Guru Medical Device Blog

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3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases - Featured Image

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Too many companies still treat risk management as a “checkbox” activity.
Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification - Featured Image

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...
eQMS in Academia: Practical Learning for Biomedical Engineering Students - Featured Image

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical devi...
Understanding the Premarket Approval (PMA) Process - Featured Image

Understanding the Premarket Approval (PMA) Process

Before any medical device can hit the US market, FDA must first evaluate the product’s potential ris...
How are Medical Devices Classified under EU MDR? - Featured Image

How are Medical Devices Classified under EU MDR?

One of the most important steps in bringing a medical device to market in the European Union (EU) is...
Tips for Running Better Management Reviews - Featured Image

Tips for Running Better Management Reviews

How efficient are your management reviews? Could improvements be made? It might be time to reevaluat...
How to Apply IEC 62304 Requirements for Medical Device Software - Featured Image

How to Apply IEC 62304 Requirements for Medical Device Software

If you’re developing a medical device that uses software, or developing SaMD (Software as a Medical ...
Understanding the FDA Medical Device Classification System - Featured Image

Understanding the FDA Medical Device Classification System

The world of medical devices is one of the most varied and complex industries around today. Innovati...
Meet a Guru: Ryan Behringer - Featured Image

Meet a Guru: Ryan Behringer

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device com...
Navigating the MedTech Cybersecurity Ecosystem - Featured Image

Navigating the MedTech Cybersecurity Ecosystem

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the U...
Cybersecurity for Medical Devices: Best Practices from Regulatory Standards - Featured Image

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards

As more and more medical devices utilizing network connection technology are developed, cybersecurit...
Choosing and Managing Your Medical Device Suppliers - Featured Image

Choosing and Managing Your Medical Device Suppliers

Managing your medical device suppliers is a core responsibility of manufacturers.

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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