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Human Factors & Risk Management: What's Needed & Why? - Featured Image

Human Factors & Risk Management: What's Needed & Why?

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human f...
What are the Opportunities for Improvement (OFI) for Quality? - Featured Image

What are the Opportunities for Improvement (OFI) for Quality?

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportuniti...
Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph - Featured Image

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emoti...
What is the Best Way to Structure a Risk Management File? - Featured Image

What is the Best Way to Structure a Risk Management File?

The medical device risk management process relies heavily on the use of documentation. Whether the a...
Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR - Featured Image

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

The European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Regulat...
How to Select a Contract Manufacturer - Featured Image

How to Select a Contract Manufacturer

What is the best way for medical device professionals, early-stage, and established companies to sel...
A Regulatory Gap Analysis of FDA's Systems & Policies - Featured Image

A Regulatory Gap Analysis of FDA's Systems & Policies

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improv...
Bill of Materials (BOM) for Medical Devices: Everything You Need To Know - Featured Image

Bill of Materials (BOM) for Medical Devices: Everything You Need To Know

When it comes to complexity, medical devices run the gamut.
Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat - Featured Image

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

How can early-stage medical device companies improve product quality, increase creativity, get to ma...
Bringing Innovation and Quality to the Forefront | Greenlight Guru Acquires CanvasGT - Featured Image

Bringing Innovation and Quality to the Forefront | Greenlight Guru Acquires CanvasGT

Greenlight Guru Acquires CanvasGT to Dramatically Enhance Iterative Design Planning for Medical Devi...
Understanding the Quality Control Process in Medical Device Manufacturing - Featured Image

Understanding the Quality Control Process in Medical Device Manufacturing

The goal of any medical device is to improve the lives of its users.
Best Practices for an Effective Medical Device Design Transfer Process - Featured Image

Best Practices for an Effective Medical Device Design Transfer Process

If you’re looking for information on design controls and product development, you can find a practic...

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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