Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru | 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 nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Connect with me:
https://www.linkedin.com/in/jondspeer https://twitter.com/greenlightguru jon.speer@greenlight.guru https://www.greenlight.guru/

Author's Posts

7 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

7 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on January 15, 2020

When it comes to regulatory compliance for medical device companies, there can be some confusion aro...

The Art of Defining Design Inputs And Design Outputs - Featured Image

The Art of Defining Design Inputs And Design Outputs

By Jon Speer on January 8, 2020

Design inputs are the king of medical device product development. If a product that is in the market...

15 Questions to Ask QMS Software Vendors in the Medical Device Industry - Featured Image

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

By Jon Speer on January 5, 2020

As a medical device company, you are expected to deliver innovative, life-changing medical device(s)...

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid - Featured Image

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

By Jon Speer on November 27, 2019

If you’re a medical device company selling or planning to sell into the US market, you should be fam...

State of Medical Device Product Development and Quality Management Report 2020 - Featured Image

State of Medical Device Product Development and Quality Management Report 2020

By Jon Speer on November 25, 2019

Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...

Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019

In an industry that is ever-evolving, change is inevitable.

7 Tips to Attract Investors and Raise Funds for your Medical Device - Featured Image

7 Tips to Attract Investors and Raise Funds for your Medical Device

By Jon Speer on October 13, 2019

Is your medical device company in the midst of raising funds or planning to begin the process? There...

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company - Featured Image

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

By Jon Speer on October 6, 2019

As a medical device manufacturer, your quality management system is the heart of your operations.

Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

By Jon Speer on September 15, 2019

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...

5 Tips from MedTech Executives on the Value of Quality - Featured Image

5 Tips from MedTech Executives on the Value of Quality

By Jon Speer on September 8, 2019

When it comes to making medical devices, quality is key.

Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

By Jon Speer on August 25, 2019

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...

What is a Quality Culture? (and 7 tips for creating one) - Featured Image

What is a Quality Culture? (and 7 tips for creating one)

By Jon Speer on July 28, 2019

In the medical device industry, the word quality can mean different things to different people. To s...