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...

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...

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

By Nick Tippmann on March 29, 2021

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself?...

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...

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...

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

By Nick Tippmann on March 3, 2021

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a m...

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...

How does EU MDR impact your Quality Management System?

By Nick Tippmann on February 22, 2021

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...

Virtual Auditing in a Post-COVID World of Digital Compliance

By Nick Tippmann on February 17, 2021

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...

Greenlight Guru Medical Device Blog