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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

What is a “Quality Data Source” for your CAPA Process? - Featured Image

What is a “Quality Data Source” for your CAPA Process?

There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...
Tips for Conducting Better Root Cause Analysis for Medical Device Companies - Featured Image

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

At some point, every medical device development company will encounter an issue that requires an inv...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Over years of working with medical device companies, we’ve found that there is a particular area tha...
Key Actions for Effective Customer Complaint Handling - Featured Image

Key Actions for Effective Customer Complaint Handling

  Let's say, your medical device business has received a complaint from a customer. It happens to al...
5 Tips for Medical Device Engineers on FDA Design Controls - Featured Image

5 Tips for Medical Device Engineers on FDA Design Controls

If you’re in the medical device industry, you may think that design controls are a confusing imposit...
9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit - Featured Image

9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit

Most of us really don’t get excited by the prospect of any kind of audit. The procedures, the paperw...
Best Practices for Expediting Your Medical Device Product Development - Featured Image

Best Practices for Expediting Your Medical Device Product Development

Speed to market is one of the major challenges for medical device companies; how can you expedite th...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...
What is CAPA in the Medical Device Industry? - Featured Image

What is CAPA in the Medical Device Industry?

If you’re relatively new to the medical device development industry, you will have worked out fairly...
Key Challenges for Risk Management in Medical Device Development - Featured Image

Key Challenges for Risk Management in Medical Device Development

If you’re in the business of developing medical devices, then risk and risk management become terms ...
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...
A Review of the Most Important Medical Device Industry Topics in 2016 - Featured Image

A Review of the Most Important Medical Device Industry Topics in 2016

2016 was a very active and monumental year for the medical device industry. There were several impor...

The greenlight.guru Medical Device Blog

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