Medical Devices: Making the Right Choice — Your Case for Quality

An FDAnews FREE Webinar • Sponsored by PTC
Recorded June 8, 2017

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The Case for Quality allows firms to determine how products are performing in real-world scenarios during all three lifecycle stages — premarket, production and post-production. By developing metrics across the total product lifecycle, companies will be able to better assess their critical quality practices.

Failure to adhere to FDA, EU, and other standards and regulations can lead to embarrassing and costly product recalls. The Case for Quality and compliance is critical.

Join Mark Turner, Technical Manager for Development IT at Novartis and Michelle Boucher, Vice President for Research at Tech-Clarity on June 8 for a discussion on current industry trends including:  

  • The Case for Quality and how manufacturers can bridge current gaps
  • How manufacturers should respond to rigid FDA or EU regulations and authorities
  • Novartis’ approach to the Case for Quality and how they apply current trends in practice


Meet Your Presenters


Mark Turner

Service Delivery Manager, Engineering, Novartis/Alcon

Mark Turner has worked at Alcon Laboratories, Inc. for 8 years. Alcon is a subsidiary of Novartis, a global healthcare company providing solutions to address the evolving needs of patients worldwide. Alcon offers a wide spectrum of eye care products. They provide innovative products that enhance quality of life by helping people worldwide see better. Mark is currently the Service Delivery Manager for Engineering and based in the Dallas/Fort Worth, supporting a Part 11 FDA Compliant Product Lifecycle Management Global Solution. His responsibilities include quality management, product analytics, and CM2 process for a full design control implementation.


Michelle Boucher

Vice President for Research, Tech-Clarity

Michelle has spent over 20 years in various roles in engineering, marketing, management, and as an analyst. She has broad experience with topics such as product design, simulation, systems engineering, mechatronics, embedded systems, PCB design, improving product performance, process improvement and mass customization. Michelle is an experienced researcher and author and has benchmarked over 7000 product development professionals and published over 90 reports on product development best practices. She focuses on helping companies manage the complexity of today’s products, markets, design environments, and value chains to achieve higher profitability.

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