greenlight.guru Medical Device Blog

Get the latest updates from our blog:

Jon Speer

Jon Speer
Jon is the founder and VP of QA/RA at greenlight.guru (quality management software exclusively for medical device companies) & a medical device guru with over 18+ years industry experience. Jon knows bringing a device to market is hard, so he built greenlight.guru to make it easier.

Author's Posts

The Risk Management + Design Controls Connection: What Device Makers Need to Know - Featured Image

The Risk Management + Design Controls Connection: What Device Makers Need to Know

This eBook was originally published as a guest expert three, part, series on Med Device Online.   Yo...
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group - Featured Image

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group

Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later thi...
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 greenlight.guru Advantage - More Than QMS Software [Customer Video Testimonial] - Featured Image

The greenlight.guru Advantage - More Than QMS Software [Customer Video Testimonial]

What do you know about greenlight.guru? Your first thought may be that greenlight.guru is a software...
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

This article was originally published on Med Device Online as part of my guest expert series. You ca...
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development - Featured Image

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

  "Medical device companies must document Design Controls, yet most struggle with this. greenlight.g...
Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to greenlight.guru - Featured Image

Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to greenlight.guru

“The proof is in the pudding. We passed our California audit with flying colors. She was in and out ...
5 Reasons Why You Need To Implement a QMS Now or Bust! - Featured Image

5 Reasons Why You Need To Implement a QMS Now or Bust!

Look, I get it. Worrying about implementing a quality management system isn't on your list of the to...

The greenlight.guru Medical Device Blog

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