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Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner - Featured Image

Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner

If you are part of an organization developing or producing Class II medical devices, you should know...
Is Your Company Disconnected from the Medical Device Regulations It Must Abide By? - Featured Image

Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?

As I type this post, I must admit that I’m a little perplexed. It seems medical device company after...
The Definitive Guide to Responding to FDA 483 and Warning Letters - Featured Image

The Definitive Guide to Responding to FDA 483 and Warning Letters

Should you ever have an FDA inspection, you’re going to want to know what to do after. And if you’re...
ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements - Featured Image

ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

Medical device companies, listen up. There is zero excuse for not complying with medical device qual...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

How To Prepare for an FDA Inspection (Plus 5 Tips) - Featured Image

How To Prepare for an FDA Inspection (Plus 5 Tips)

Over the past several years, FDA has been more aggressive and active in performing medical device co...
How To Flush $400,000 Down the Drain Fighting the FDA - Featured Image

How To Flush $400,000 Down the Drain Fighting the FDA

How much does it cost to address FDA 483 observation and warning letter issues? Unless you have been...
How Smart Medical Device Startups Avoid FDA Disasters [Panel Recap] - Featured Image

How Smart Medical Device Startups Avoid FDA Disasters [Panel Recap]

[<a href="//storify.com/green...
How To Avoid a Medtech Documents & Records Scavenger Hunt - Featured Image

How To Avoid a Medtech Documents & Records Scavenger Hunt

I love a scavenger hunt as much as the next person. However, when it comes to medical device documen...
5 Tips to Help Your FDA 510(k) Submission (checklist included) - Featured Image

5 Tips to Help Your FDA 510(k) Submission (checklist included)

If you are developing a medical device in the United States, there is a good chance your path to mar...
An FDA Inspection Will Happen - Featured Image

An FDA Inspection Will Happen

If you are a medical device company in the U.S., did you know FDA is required to inspect all class I...

The greenlight.guru Medical Device Blog

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