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

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...

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

By Nick Tippmann on March 26, 2020

In this modern digital world, did you know that most medical devices are not connected to the Intern...

Medical Device Companies - Top 100 in 2020 (Free Chart)

By Nick Tippmann on March 24, 2020

Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...

How to Leverage IEC 62304 to improve SaMD Development Processes

By Nick Tippmann on March 18, 2020

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

By Nick Tippmann on March 12, 2020

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

By Nick Tippmann on March 9, 2020

Medical device quality management system (MDQMS) aligns with latest version of globally recognized r...

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