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

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020

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

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 ...

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...

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) ...

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

By Nick Tippmann on January 29, 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for...

Navigating the Twists and Turns of Change Management for Medical Devices

By Nick Tippmann on December 28, 2019

Change is constant… Especially in the medical device industry. Medical device change management can ...

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

By Nick Tippmann on December 18, 2019

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...

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