Personalizing and Triaging my QMS

Presenter: Michael Drues, Ph.D

Every medical device manufacturer should (must?) have a quality management system (QMS) but should QMS’s be substantially equivalent (pun intended!)?

Absolutely NOT!  In other words, if any sections of my QMS apply to other companies or devices, it is NOT specific enough!  When during the product development process do I need a QMS?

Must I have a complete QMS or can I have only certain sections?  

How do I decide which sections I need and when I need them?  

This webinar goes beyond the basics, i.e., the mechanics of simply building a QMS. Rather, this webinar provides practical advice and answers questions not directly addressed in the Code of Federal Regulations (CFR), Quality System Regulation (QSR) or FDA Guidance Documents… or in some cases, not addressed at all!

Examples of such questions include:

• Should all QM Systems be substantially equivalent (pun intended!)?
• How and why should I personalize my QMS, i.e., make my QMS mine?
• When should or must I have my QMS in place?
• Are all sections of the QMS listed in the QSR required for all devices?
• Must I have a QMS in place to get FDA clearance or approval of my device?
• Are all sections of my QMS equally important or are some sections more important than others?
• Do I need to have a QMS if I NEVER intend to market my device?
• If my QMS is compliant, can I assume it works?
• From a product liability perspective, why is my QMS important?
• How does my QMS apply to personalized, i.e., 3-D Printed devices?
• What does the future hold?

In other words, if building a QMS is simply a matter of following the regulations, then why do so many people have so many questions and why do so many companies get in trouble with the FDA?  

'This webinar will encourage participants to think about the most important principles and philosophies of their QMS and not simply the mechanics.  Participants will learn best practices to avoid timely and costly mistakes and creative ways to use regulatory and quality requirements to their advantage!