<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 150,000+ other medical device professionals outperforming their peers.

3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

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 - Featured Image

Understanding the Investigational Device Exemption (IDE) Process

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...
Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry - Featured Image

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

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) - Featured Image

How to Use the FDA ESG (Electronic Submissions Gateway)

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? - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

Everything you Need to Know about SaMD from an FDA Perspective

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 - Featured Image

How to Use Voluntary Consensus Standards to your Strategic Advantage

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 - Featured Image

Preparing for Remote and On-Site Inspections and Audits

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? - Featured Image

How does EU MDR impact your Quality Management System?

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 - Featured Image

Virtual Auditing in a Post-COVID World of Digital Compliance

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

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

Our Most Popular Posts

Topics

See More Topics...