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

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...

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...

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) ...

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...

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

By Nick Tippmann on February 19, 2020

Regulatory is a big deal for medical device companies. Whether it’s a startup or established busines...

4 Parts to Interviewing Candidates for Medical Device Roles

By Nick Tippmann on February 12, 2020

Are you looking to hire medical device professionals? Or, are you a professional seeking new job opp...

5 Tips for Hiring Medical Device Advisors

By Nick Tippmann on February 5, 2020

Everybody seeks advice and opinions from others from time to time, even those in the medical device ...

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...

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