How To Improve Your Product & Bottom Line With Compliance & A QMS

Isabella Schmitt, Director of Regulatory Affairs at Proxima, is here to help webinar participants learn how regulations, standards, and a QMS all come together to create a better, safer product and improve your bottom line.

Specifically this webinar will review:

• History Before Regulations – Learn how regulations reshaped the landscape of medical product development.
• Standards vs. Regulation – The connection, overlap, and how these two influence one another.
• Quality to safer devices – Learn how monitoring and maintaining standards improve efficacy and efficiency in manufacturing safer products.
• Pre-market requirements – Here’s what you need to know before your product gets to market, including developing QMS and Design Controls.
• Post-market requirements – Is your product already on market? Here’s how to use PMS and what else you need to keep in mind after your product is readily available to the public.
• FDA and ISO – Learn about the impact of ISO standards how they affect FDA regulation