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Nonbinding Feedback is a New Guidance You Should Know About - Featured Image

Nonbinding Feedback is a New Guidance You Should Know About

By Nick Tippmann on March 8, 2019
FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...
Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams - Featured Image

Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams

By Nick Tippmann on March 5, 2019
Medical device quality management system debuts flexible design review capabilities for devices with...
How and When to Consider Human Factors - Featured Image

How and When to Consider Human Factors

By Nick Tippmann on February 28, 2019
When should you begin to consider human factors with your medical device design and development effo...
Quality, Fast, Cheap...Pick Two - Featured Image

Quality, Fast, Cheap...Pick Two

By Mark D Proulx, CQA, cSSBB on February 24, 2019
You may think you're saving the company money by using that "free" Excel spreadsheet to track design...
Who Should Own Your QMS? - Featured Image

Who Should Own Your QMS?

By Nick Tippmann on February 21, 2019
Does your medical device company prefer to outsource the responsibility of its quality management sy...
What to Expect During an FDA QSIT Inspection - Featured Image

What to Expect During an FDA QSIT Inspection

By Jon Speer on February 17, 2019
You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are...
Design Validation vs. Human Factors Validation - Featured Image

Design Validation vs. Human Factors Validation

By Nick Tippmann on February 13, 2019
  Human factors and risk create a lot of confusion in the medical device industry. What do you need ...
5 Most Common Problems with your CAPA Process - Featured Image

5 Most Common Problems with your CAPA Process

By Jon Speer on February 10, 2019
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

By Nick Tippmann on February 6, 2019
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

By Nick Tippmann on January 29, 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

By Jon Speer on January 29, 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

By Nick Tippmann on January 25, 2019
Regulatory compliance is critically important. However, some think product liability is just as impo...

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