Description

Most people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start, and how do you know when you've built it to the point it can stand on this own?

In this episode, Rob MacCuspie, PhD, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, Inc., discusses the best practices of companies he has worked with to help implement their Quality Management System in a manageable way.

Takeaways:

1. What is the difference in your QMS and a Document Management System?
2. What is the most important aspect of a QMS?
3. Who really needs a QMS, and when?
4. What are the phases of a QMS?
5. How to start building a QMS.

Quote:

""If my SOPs and training process can bring in somebody that has no experience and they can hit the ground running, I'm not worried if the auditor has any experience now in my space, right. Because I now have everything in place to show somebody how they can teach themselves and learn and get up to speed and walk through the process."

Reference Links:

• Rob MacCuspie on LinkedIn
• Etienne Nichols on LinkedIn
• Proxima Clinical Research
• Greenlight Guru software