| Compliance issues and device recalls can cost millions of dollars, resulting in Food and Drug Administration (FDA) warnings, or irreversible damage to medical device companies. Many product recalls can be traced to poor product design controls. Meeting the FDA regulations without sacrificing speed to launch products is critical. Design controls are not only a regulatory requirement—they lay the foundation for proper design and development of medical devices and provide device manufacturers with the opportunity to address issues early in the design process. Don’t miss out on this panel discussion with leading quality veterans as they share how they’ve overcome challenges meeting design controls requirements.
During this webinar, you will learn how to:
- Understand the key elements of design controls
- Determine the best approach to meet design controls requirements
- Better mitigate risk management issues
- Overcome design controls hurdles
Ann McGuire
Manager, Product Marketing
Arena Solutions
Ann McGuire is a product marketing manager at Arena Solutions . She has held consulting, sales, and marketing positions in the PLM and QMS industry over the past 25 years. Prior to working in PLM, Ann was an engineer in the semiconductor acquisition and test group for a major computer company.
Christopher Hill, CQE, CMQ-OE, RAC
Director of Quality Assurance
Organ Recovery Systems, Inc.
Christopher Hill has served as the Director of Quality for Organ Recovery Systems since 2014. He has a bachelor’s degree in Biology from Carthage College and a master’s degree in Business Administration from Devry University. Christopher holds certifications as a Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE) from the American Society for Quality, as well as Regulatory Affairs Certification (US RAC) from the Regulatory Affairs Professionals Society.
Vis Ayer
Sr. Director of Quality
Nevro
Vis Ayer is the Sr. Director of Quality for Nevro and has over 15 years of progressive experience in the medical device industry. He leads the Nevro Quality Assurance group and is responsible for ensuring regulatory compliance with FDA, ISO, and other regulatory standards. Vis and his team establish and maintain critical quality processes spanning supplier controls, complaint investigation, software quality assurance, product quality, corrective and preventive actions (CAPA), facility inspections, and design controls. Vis has a master’s degree in electrical engineering from New Jersey Institute of Technology.
Nancy Crotti
Moderator
Senior Editor, Medical Design and Outsourcing
Nancy Crotti is a veteran journalist based in St. Paul, Minnesota. She has written and edited articles on numerous topics, focusing on the medical device business for the past four years.
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Register at https://www.medicaldesignandoutsourcing.com/webinar-quality-experts-share-keys-to-medical-device-design-controls-success/
