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Greenlight Guru Medical Device Blog

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Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies - Featured Image

Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies

Greenlight Guru is proud to announce that it has been selected - by users - as the leading QMS for t...
Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs - Featured Image

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. W...
Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4) - Featured Image

Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4)

To obtain a CE marking and market your medical device in the EU, you’ll first need to perform a clin...
4 Problems (and Solutions) for the Medical Device Supply Chain - Featured Image

4 Problems (and Solutions) for the Medical Device Supply Chain

If you had told me three years ago that supply chain economics and logistics would become a popular ...
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices - Featured Image

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the in...
Understanding Technical Documentation in EU Regulations - Featured Image

Understanding Technical Documentation in EU Regulations

Generally speaking, technical documentation is the compilation of documents that explains how a prod...
Let The Document Tell The Story: Document Management Best Practices - Featured Image

Let The Document Tell The Story: Document Management Best Practices

Good stories follow a 3-act structure: Act 1: Set up Act 2: Conflict Act 3: Resolution “Thanks a lot...
QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies - Featured Image

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...
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...
Software Bill of Materials: What to Know About SBOMs for Medical Devices - Featured Image

Software Bill of Materials: What to Know About SBOMs for Medical Devices

On May 12, 2021, President Biden signed the Executive Order On Improving the Nation’s Cybersecurity....
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...

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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