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Greenlight Guru Medical Device Blog

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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...
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...
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.
FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Would things be simpler in the medical device regulatory space if there was global harmonization acr...
Meet a Guru: Sara Adams - Featured Image

Meet a Guru: Sara Adams

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical d...
Everything you Need to Know about SaMD from an FDA Perspective - Featured Image

Everything you Need to Know about SaMD from an FDA Perspective

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are i...
Preparing for Remote and On-Site Inspections and Audits - Featured Image

Preparing for Remote and On-Site Inspections and Audits

How can medical device companies be better prepared for remote and on-site inspections and audits? P...
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...
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...
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...
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
Understanding Change Management and Change Control in the Medical Device Industry - Featured Image

Understanding Change Management and Change Control in the Medical Device Industry

Change is inevitable in the medical device industry. Innovative device companies are at the constant...

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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