Greenlight Guru Medical Device Blog

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Challenging “Conventional Wisdom” in Medtech R and D - Featured Image

Challenging “Conventional Wisdom” in Medtech R and D

  The idea of “research versus development” can be highly controversial and much-debated among medic...
How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years - Featured Image

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

  Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have ...
What Medical Device Developers Should Know About Human Factors - Featured Image

What Medical Device Developers Should Know About Human Factors

  Human factors can be a topic rife with confusion for medical device developers. What do they mean?...
Understanding the 5 Phases of Medical Device Development - Featured Image

Understanding the 5 Phases of Medical Device Development

Do you have a medical device to launch? Well I have good news for you and I have bad news for you.
4 Tips for Handling Nonconformances - Featured Image

4 Tips for Handling Nonconformances

The safety and efficacy of your product rides heavily on the quality of the components that make it ...
Ultimate List of Medical Device Incubators and Accelerators (50+) - Featured Image

Ultimate List of Medical Device Incubators and Accelerators (50+)

Medical startups around the United States face many of the same challenges when it comes to achievin...
15 Steps to Getting Approval for IEC 60601-1 - Featured Image

15 Steps to Getting Approval for IEC 60601-1

  Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE)...
How to Integrate Complaint Handling and Risk Management - Featured Image

How to Integrate Complaint Handling and Risk Management

Did you know that complaint handling continues to be a big reason medical device companies receive 4...
Here Are the 4 Types of FDA Inspections You Need to Understand - Featured Image

Here Are the 4 Types of FDA Inspections You Need to Understand

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

It’s every medical device manufacturer's favorite time… … the arrival of an FDA inspector or ISO aud...
How to Translate Voice of Customer into User Needs - Featured Image

How to Translate Voice of Customer into User Needs

  How well do you do at capturing “voice of customer” and translating into user needs?

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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