Medical Device Quality, Regulatory and Product Development Blog

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

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?

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

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

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

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

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

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

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

By Nick Tippmann on January 25, 2019

Regulatory compliance is critically important. However, some think product liability is just as impo...

Best Practices for Effective Medical Device Design Reviews

By Jon Speer on January 20, 2019

Design Reviews are intended to be checkpoints during medical device product development to ensure th...

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 17, 2019

One thing that seems to be constant in the global medical device industry is change.

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