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Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm - Featured Image

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

By Nick Tippmann on April 19, 2019
Do you love quality and regulatory and keeping up with all things related to the medical device indu...
Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices - Featured Image

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

By Nick Tippmann on April 11, 2019
It seems like every time you turn on the TV, there’s commercials, movies, and shows that highlight t...
Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway - Featured Image

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

By Nick Tippmann on March 27, 2019
FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pe...
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...
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...
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...
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 ...
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...
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...
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?

By Nick Tippmann on January 16, 2019
Do you know the difference between quality management system (QMS) and quality systems management (Q...
Aligning True Quality and Compliance with MDDAP - Featured Image

Aligning True Quality and Compliance with MDDAP

By Nick Tippmann on January 9, 2019
What does true quality mean? How does it relate to compliance?
Explaining the Significance of Voluntary Consensus Standards - Featured Image

Explaining the Significance of Voluntary Consensus Standards

By Nick Tippmann on January 2, 2019
What are Voluntary Consensus Standards? Why should you care about them? What role do they play in yo...

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