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

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...
8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a l...
Acronyms You Need To Know When Evaluating Medical Device Software Solutions - Featured Image

Acronyms You Need To Know When Evaluating Medical Device Software Solutions

Ah, yes! You aspire to run your device company in a paperless environment. Allowing you to capture a...
6 Medical Device Product Development Steps To Fast-Track Your Path To Market - Featured Image

6 Medical Device Product Development Steps To Fast-Track Your Path To Market

This article originally appeared as a guest expert post on Med Device Online. Congratulations! You h...
Why Medical Device Startups Need to Master Juggling and Balancing With Focus - Featured Image

Why Medical Device Startups Need to Master Juggling and Balancing With Focus

Medical device startups are faced with numerous challenges and obstacles to get their products to ma...
How Design Controls Apply to a 510(k) - Featured Image

How Design Controls Apply to a 510(k)

If you are developing a medical device for the U.S. market, you first need to determine how your dev...
Why FMEA is NOT ISO 14971 Risk Management - Featured Image

Why FMEA is NOT ISO 14971 Risk Management

If you are still using FMEA as your methodology to capture medical device risk management activities...
Top 3 Document Management Tips for Medical Device Companies - Featured Image

Top 3 Document Management Tips for Medical Device Companies

This co-authored article originally appeared as a guest post on Quality Digest. In the medical devic...
How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls - Featured Image

How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

Click here to enlarge image. The story I’m about to tell you is about Eddy Engineer and his trials a...
4 Reasons Why Your Risk Management Approach is Wrong - Featured Image

4 Reasons Why Your Risk Management Approach is Wrong

This article originally appeared as a guest post on MedTech Intelligence. A few months ago, I predic...

The greenlight.guru Medical Device Blog

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