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5 Most Common Problems with your CAPA Process - Featured Image

5 Most Common Problems with your CAPA Process

Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...
Medical Device Product Development Value Proposition - Featured Image

Medical Device Product Development Value Proposition

It doesn’t matter how long a company has been in business. Both startups and established companies n...
Top 35+ Medical Device Conferences To Attend in 2019 - Featured Image

Top 35+ Medical Device Conferences To Attend in 2019

Simply attending the right conferences can be a game-changer for those in the medical device industr...
Introducing The Greenlight Guru True Quality Roadshow 2019 - Featured Image

Introducing The Greenlight Guru True Quality Roadshow 2019

To the Medical Device Community, From the moment Greenlight Guru was founded, we have taken our lead...
Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies - Featured Image

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Regulatory compliance is critically important. However, some think product liability is just as impo...
Best Practices for Effective Medical Device Design Reviews - Featured Image

Best Practices for Effective Medical Device Design Reviews

Design Reviews are intended to be checkpoints during medical device product development to ensure th...
Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference? - Featured Image

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Do you know the difference between quality management system (QMS) and quality systems management (Q...
Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too - Featured Image

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...
Aligning True Quality and Compliance with MDDAP - Featured Image

Aligning True Quality and Compliance with MDDAP

What does true quality mean? How does it relate to compliance?
Why Contract Manufacturers Shouldn't Own Your Quality System - Featured Image

Why Contract Manufacturers Shouldn't Own Your Quality System

Does your medical device company use a third-party or contract manufacturer?
Explaining the Significance of Voluntary Consensus Standards - Featured Image

Explaining the Significance of Voluntary Consensus Standards

What are Voluntary Consensus Standards? Why should you care about them? What role do they play in yo...
FDA Case for Quality: 2018 Comprehensive Review - Featured Image

FDA Case for Quality: 2018 Comprehensive Review

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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