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How does EU MDR impact your Quality Management System? - Featured Image

How does EU MDR impact your Quality Management System?

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...
Why a Visual QMS is So Important for Your Medical Device Company - Featured Image

Why a Visual QMS is So Important for Your Medical Device Company

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...
5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes - Featured Image

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...
Ultimate Guide to Training Management for Medical Device Companies - Featured Image

Ultimate Guide to Training Management for Medical Device Companies

Understanding ISO 13485 Training and Competency Requirements - Featured Image

Understanding ISO 13485 Training and Competency Requirements

Are the employees in your medical device company meeting the training and competency requirements of...
How Does a Medical Device Quality Management System Differ from other QMS Tools? - Featured Image

How Does a Medical Device Quality Management System Differ from other QMS Tools?

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...
6 Benefits of the Best 21 CFR Part 11 Compliant Software - Featured Image

6 Benefits of the Best 21 CFR Part 11 Compliant Software

Nearly every medical device company is subject to software validation requirements, regardless of wh...
Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices - Featured Image

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

Positive and Negative Impacts of EUA on the Medical Device Industry - Featured Image

Positive and Negative Impacts of EUA on the Medical Device Industry

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly uti...
Everything You Need to Know about Human Factors Engineering for Your Medical Device - Featured Image

Everything You Need to Know about Human Factors Engineering for Your Medical Device

Human factors are a key part of medical device development and the sooner they’re addressed in the d...
The Ultimate Internal Audit Checklist Every Medical Device Company Needs - Featured Image

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

It was nothing more than a checklist that saved $175 million and 1,500 lives.
Free Complaint Template for Medical Devices - Featured Image

Free Complaint Template for Medical Devices

One of the major post-market responsibilities of medical device companies is handling customer compl...

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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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