American Society of Quality Dinner Forum 

Speaker Topic: A Risk-based Compliance Strategy for Emerging Companies in the Medical Device, Software, Mobile, Wireless and Digital Health Space  

Traditional med-tech companies with traditional software-controlled medical devices know how to fulfill FDA requirements.  However there's an increasing urgency to understand and properly scale Quality Systems, SDLC, and V&V requirements.  These requirements will address the needs of non-traditional device, software, mobile medical, wireless and digital health companies so they can navigate the risk-based regulatory framework. 

This talk will examine a framework for determining software level of concern and adapting what's needed to meet FDA compliance expectations while addressing business speed-to-market for high-quality software.

n Register Now! 

   

Ms. Mary Beth McDonald

Speaker Biography:

Mary Beth McDonald has over 25 years of Quality Assurance and Regulatory Compliance experience in the medical device and biotech industries.  She has worked on Class III implantable pacemakers and defibrillators remote monitoring devices, drug deliverable combiation devices, and mobile medical devices and diagnostics.

Currently Ms. McDonald is the Sr. Director of Quality Assurance at Alexsa Parmaceuticals, working on a drug delivery combination product.  Prior to her current role,she was the Director of Software Design Assurance at St. Jude's where she spent 17 years leading a team of quality engineers.

 

Meeting agenda:

• 5:00 - 5:30 - Check In & Registration
• 5:30 - 6:10 - Networking
• 6:15 - 6:55 - Dinner
• 6:55 - 7:10 - Section Business: Don Mintz, Section Chair
• 7:10 - 8:25 - Ms. Mary Beth McDonald: A Risk-based Compliance Strategy for Emerging Companies in the Medical Device, Software, Mobile, Wireless and Digital Health Space
• 8:25 - 8:30 - Door Prize drawing

 

Registration- a three part process:1) having a meal? and 2) select meal if you are having one  3) pay for the meal via PayPal

• Advance $35
• Late/Walk-in $40
• Unemployed $20
• Presentation only and special guests $0

Note: Advance registration ends at midnight Monday May 18th

 E-mail questions regarding dinner meetings to:

 programs@asq-silicon-valley.org

The ASQ Silicon Valley Leadership Team hopes to see you all at our dinner meeting!

 Register Now!