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3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US - Featured Image

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

Anyone who works in the medical device industry will tell you that quality and patient care is of th...
Debunking 4 Commonly Held Design Control Myths - Featured Image

Debunking 4 Commonly Held Design Control Myths

The design control struggle is real.What is the struggle, you ask? Design controls are not being use...
True Quality: Greenlight Guru consistently ranked the #1 QMS by users for three years in a row - Featured Image

True Quality: Greenlight Guru consistently ranked the #1 QMS by users for three years in a row

Greenlight Guru is proud to announce that for three years straight, we have been named the leader in...
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc - Featured Image

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the...
What is the FDA Medical Device Registration Process? - Featured Image

What is the FDA Medical Device Registration Process?

To patients and providers, medical devices are more than a product. They serve as the conduit to bet...
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
Top 3 Reasons for FDA 483 Observations in 2020 - Featured Image

Top 3 Reasons for FDA 483 Observations in 2020

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...
How to Use the MDSAP Companion Document - Featured Image

How to Use the MDSAP Companion Document

When people speak of bringing a medical device “to market,” the location of that market is often lef...
Addressing the 'Who, What, When' of Quality in the Medical Device Industry - Featured Image

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

There are many schools of thought when it comes to the 'who, what, and when' of quality management f...
3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers - Featured Image

3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers

Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and ...
Goodbye EN 1041. Hello ISO 20417:2021. - Featured Image

Goodbye EN 1041. Hello ISO 20417:2021.

When you’re trying to bring a new medical device to market, it’s normal to be focused on actually bu...
Driving Medtech Innovation with Safe and Effective Medical Devices - Featured Image

Driving Medtech Innovation with Safe and Effective Medical Devices

In the medical device industry, innovation is a complicated subject.

The Greenlight Guru Medical Device Blog

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

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