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

3 Systems of Risk for Medical Devices from FDA

By Nick Tippmann on April 7, 2021

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...

Am I Complying with FDA Medical Device Labeling Requirements?

By Jesseca Lyons on April 4, 2021

Medical device labeling requirements are a key part of getting your device to market.

Understanding the Investigational Device Exemption (IDE) Process

By Nick Tippmann on March 31, 2021

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...

How to Use the FDA ESG (Electronic Submissions Gateway)

By Tom Rish on March 28, 2021

The most competitive medical device companies embrace technology as a tool to make systems and proce...

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

By Nick Tippmann on March 21, 2021

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices f...

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

By Nick Tippmann on March 16, 2021

The IVD market reaches into all corners of the world, and for many device companies, this niche prod...

Why the PMA Process is so Dreaded by Manufacturers in the US Market

By Nick Tippmann on March 15, 2021

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that h...

Building a Startup in the MedTech Industry

By Nick Tippmann on March 10, 2021

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and th...

How to Demonstrate Substantial Equivalence in 5 Easy Steps

By Tom Rish on March 7, 2021

If you’re taking the 510(k) route to market for your medical device, demonstrating substantial equiv...

Everything you Need to Know about SaMD from an FDA Perspective

By Nick Tippmann on March 1, 2021

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are i...

How to Use Voluntary Consensus Standards to your Strategic Advantage

By Taylor Brown on February 28, 2021

If we were to say that it’s okay if you don’t follow all relevant standards when you develop your me...

Preparing for Remote and On-Site Inspections and Audits

By Nick Tippmann on February 24, 2021

How can medical device companies be better prepared for remote and on-site inspections and audits? P...

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