Jon Speer

VP of QA/RA

greenlight.guru

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.

 

Thu, 10/13/2022 - 12:03
Top Three Document Management Tips for Medical Device Companies Avoid the headache (and citations) by establishing electronic document control
Wed, 07/08/2015 - 12:00
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation. We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to…
Eight Questions That Define Your Medical Device User Needs Don’t start with what the device does; start with who it’s for
Tue, 04/21/2015 - 13:20
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet…