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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 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...
15 Items Medical Device Startups Need to Address - Featured Image

15 Items Medical Device Startups Need to Address

As a medical device startup, there are many things you are juggling and balancing all day, every day...
Paper Systems Are the Riskiest Way to Manage Medical Device Projects - Featured Image

Paper Systems Are the Riskiest Way to Manage Medical Device Projects

Did you know that over 50% of medical device companies still use manual, paper-based approaches for ...
A Step-by-Step Guide to Determine How Your Medical Device Will Be Classified - Featured Image

A Step-by-Step Guide to Determine How Your Medical Device Will Be Classified

What I am about to share with you is a guide to medical device regulatory classification. In this gu...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

The greenlight.guru Medical Device Blog

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