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

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020

What is a regulatory strategy? What are the components involved?

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

By Nick Tippmann on May 20, 2020

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

By Nick Tippmann on May 13, 2020

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

By Nick Tippmann on May 6, 2020

What does the 510(k) process involve? How should medical device companies know if this is the right ...

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

By Nick Tippmann on April 29, 2020

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for fr...

Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies

By Nick Tippmann on April 27, 2020

Bundled offerings equip medical device manufacturers to better navigate regulatory pathways, bring d...

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

By Nick Tippmann on April 22, 2020

What impact will the EU MDR changes have on the medical device ecosystem?

How to Approach Verification and Validation for Cloud Software

By Nick Tippmann on April 15, 2020

Why is verification and validation (V&V) confusing and challenging for many medical device professio...

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

By Nick Tippmann on April 10, 2020

During the COVID-19 crisis, medical device companies are improving and saving the lives of healthcar...

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

By Nick Tippmann on April 8, 2020

What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this r...

10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead

By Nick Tippmann on April 4, 2020

During unprecedented times, medical device companies are finding themselves facing unusual challenge...

How to Integrate Usability into your Medical Device

By Nick Tippmann on April 1, 2020

Medical device usability is a critical, yet confusing component of medical device design, developmen...

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Nick Tippmann

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