Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

By Nick Tippmann on June 17, 2020

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focu...

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

By Nick Tippmann on October 11, 2019

Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers,...

Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

By Nick Tippmann on August 9, 2019

In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative,...

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

By Nick Tippmann on July 26, 2019

Patients, providers, and companies are already experiencing the benefits of FDA’s Case for Quality P...

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

By Nick Tippmann on July 12, 2019

If you or your child have ever experienced ear infections, you know how difficult (and painful) they...

Creating a Culture of Quality for Medical Device Companies

By Nick Tippmann on June 21, 2019

Is creating a culture of quality a top priority at your MedTech company? But you’re not sure how or ...

Improving the Colon Cancer Screening Experience

By Nick Tippmann on May 24, 2019

Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasi...

Advancing MRI Technology As We Know It Today

By Nick Tippmann on May 10, 2019

The field of radiology is constantly changing and evolving overtime. One MedTech innovator who's lea...

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

By Nick Tippmann on April 26, 2019

Within the medical device industry, there’s a right way and a wrong way to address quality and compl...

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

By Jon Speer on April 7, 2019

I'm thrilled to announce the officially launch of Greenlight Guru's second podcast series, MedTech...

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

By Nick Tippmann on April 7, 2019

How do medical device companies approach the “scaries” related to quality and guidance regulations w...

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants