greenlight.guru Medical Device Blog

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3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...
3 Common Misconceptions About Medical Device Labeling - Featured Image

3 Common Misconceptions About Medical Device Labeling

When you first start designing and developing a new medical device, you spend a bunch of time learni...
4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer - Featured Image

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

As an engineer, there’s not a lot that makes me nervous.   Going through an FDA / ISO audit?   That ...
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important) - Featured Image

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

It’s time to break down the how and why of intended use and indications of use statements for your n...
How Design Controls Apply to a 510(k) - Featured Image

How Design Controls Apply to a 510(k)

If you are developing a medical device for the U.S. market, you first need to determine how your dev...
Why FMEA is NOT ISO 14971 Risk Management - Featured Image

Why FMEA is NOT ISO 14971 Risk Management

If you are still using FMEA as your methodology to capture medical device risk management activities...
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner - Featured Image

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Standards are absolutely critical when you are developing a medical device. You need to understand w...
ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements - Featured Image

ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

Medical device companies, listen up. There is zero excuse for not complying with medical device qual...
20 Most Popular Medical Device Posts of 2015 from greenlight.guru - Featured Image

20 Most Popular Medical Device Posts of 2015 from greenlight.guru

2015 was a huge year for greenlight.guru! A lot happened. From publically launching our product in F...
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
5 Reasons Why You Need To Implement a QMS Now or Bust! - Featured Image

5 Reasons Why You Need To Implement a QMS Now or Bust!

Look, I get it. Worrying about implementing a quality management system isn't on your list of the to...

The greenlight.guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.