Medical Device Quality, Regulatory and Product Development Blog

Greenlight Guru Academy Advance: The Future of MedTech Learning is Continuous

By Nick Tippmann on May 22, 2022

When you think of learning, do you imagine a specific moment in time? Does the old cliché of a “ligh...

Building a Culture of Quality

By Nick Tippmann on May 20, 2022

How do you build a company that puts culture before function? Results before profit? Building a cult...

Bringing Medical Devices Into The Home

By Nick Tippmann on May 18, 2022

Are you passionate about human-centered design and how it relates to health care? Patients deserve a...

How to Build a Medical Device Business Case in 5 Easy Steps

By Etienne Nichols on May 16, 2022

In business, so much of success depends on timing. A product launches too early and is misunderstood...

Demystifying the De Novo Process

By Nick Tippmann on May 12, 2022

How do you navigate the De Novo process for your medical device? When do you decide to go that route...

Greenlight Guru Earns 2022 TrustRadius Top Rated Software Award

By Nick Tippmann on May 11, 2022

Greenlight Guru is thrilled to share our selection as one of the TrustRadius Top Rated products of 2...

Challenges for Regulatory Submission: EU vs. US

By Nick Tippmann on May 6, 2022

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing w...

8 Questions That Define Your Medical Device User Needs

By Laura Court on May 6, 2022

When people talk about design controls, they often place a lot of emphasis on design inputs and outp...

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

By Etienne Nichols on May 5, 2022

A Performance Evaluation (PE) is required for any in vitro diagnostic device (IVD) that a manufactur...

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

By Nick Tippmann on May 4, 2022

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezer...

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

By Etienne Nichols on May 1, 2022

Starting a new job is always a little stressful. But when you’re a new QA/RA Manager, there’s even m...

The Future of Cybersecurity

By Nick Tippmann on April 29, 2022

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers nee...

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