How the smart Orthopedic companies are hacking FDA and ISO Compliance

Building a QMS system that is compliant is a real pain for a small company.  So far, there haven’t been any QMS software solutions that are built specifically for medical device companies.   And in small companies, entrepreneurs are not focused on setting up quality systems while they are developing disruptive technology.  At least, not until now.


Jon SpeerEnter Jon Speer. 

I have known Jon for 10 years, and he is the real deal in orthopedics and medical device compliance systems.  He is the force behind the Greenlight-guru tools that will make your life easier.   Jon has made it easy.  He will save you time and effort so you can focus in innovation. He has created simple tools for daily compliance in Design Control, Document Management, and general FDA / ISO compliance.  I only wish wish his tool had been available for me at my first two startups, NovaLign and Active Implants.

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If you contact Jon now, he will throw in a bunch of bonus tools. The next two companies will get these bonus tools:

  • get a Risk Management system
  • get an electronic document management system
  • get e-signatures
  • all Part 11 compliant