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Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) - Featured Image

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

By Nick Tippmann on May 12, 2021
Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...
Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program - Featured Image

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

By Nick Tippmann on May 11, 2021
What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program...
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry? - Featured Image

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

By Nick Tippmann on May 6, 2021
Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...
Managing Business Risk as a Medical Device Company - Featured Image

Managing Business Risk as a Medical Device Company

By Nick Tippmann on May 3, 2021
It's easy to get so wrapped up in the risk management of your medical device that you forget about m...
Waterfall vs. Agile: Battle of the Product Development Methodologies - Featured Image

Waterfall vs. Agile: Battle of the Product Development Methodologies

By Nick Tippmann on April 28, 2021
Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?
For the Love of Internal Auditing - Featured Image

For the Love of Internal Auditing

By Nick Tippmann on April 26, 2021
Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me...
Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices - Featured Image

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

By Nick Tippmann on April 21, 2021
What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a ...
Knowing vs. Doing as Medical Device Professionals - Featured Image

Knowing vs. Doing as Medical Device Professionals

By Nick Tippmann on April 19, 2021
For medical device professionals, there are the “knowers” and the “doers.”
Pivoting Operations to Meet PPE Demand during Pandemic - Featured Image

Pivoting Operations to Meet PPE Demand during Pandemic

By Nick Tippmann on April 14, 2021
Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...
Pros & Cons of Being a Physician turned MedTech Inventor - Featured Image

Pros & Cons of Being a Physician turned MedTech Inventor

By Nick Tippmann on April 13, 2021
Do you fear needles and the associated pain? No one understands this fear more than physicians who s...
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

By Nick Tippmann on April 7, 2021
Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Quality Management for IVD Devices vs Medical Devices - Featured Image

Quality Management for IVD Devices vs Medical Devices

By Nick Tippmann on April 5, 2021
How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...

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