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Greenlight Guru Medical Device Blog

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Understanding and Handling Different Types of Feedback - Featured Image

Understanding and Handling Different Types of Feedback

What’s the relationship between product feedback, complaints, and adverse events? 
How to Use the De Novo Pathway for your Medical Device - Featured Image

How to Use the De Novo Pathway for your Medical Device

Is the De Novo regulatory pathway a viable option to get your medical device to market?
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?
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape - Featured Image

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device ind...
Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster - Featured Image

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

Customers benefit from expert advice to lower development costs and save time identifying the right ...
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...
Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry - Featured Image

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...
Most Popular Medical Device Content in 2020 from Greenlight Guru - Featured Image

Most Popular Medical Device Content in 2020 from Greenlight Guru

Thank you for helping make 2020 another exciting and record-breaking year for Greenlight Guru!
Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near - Featured Image

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficu...
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...
How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes? - Featured Image

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related...
2021 State of Medical Device Quality Management and Product Development Benchmark Report - Featured Image

2021 State of Medical Device Quality Management and Product Development Benchmark Report

Findings of a 2021 industry benchmark survey reveal internal divides within organizations are making...

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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