Driving a Culture of Quality for Devicemakers

An FDAnews FREE Webinar • Sponsored by Axendia
Recorded March 1, 2017

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Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?

Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.

How are the FDA and industry finding common ground creating a culture of quality?

How is the CfQ creating a competitive marketplace for device quality?

What are the market and regulatory incentives for device manufacturers?

Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco Vicenty — Program Manager, Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

You will learn:

  • How to stop routine FDA inspections and forego pre-approval inspections
  • How the Case for Quality is creating a competitive marketplace for device quality
  • What are the market and regulatory incentives for device manufacturers
  • How to manage results using quality tools
  • What are the quality outcome metrics FDA will collect and monitor
  • Why you need to manage medical devices across their total lifecycle
  • How to drive accelerated innovation volume and velocity
  • How to use an integrated approach to manage increasing device complexities
  • How to sharpen your focus on developing high quality medical devices aimed at improving patient outcomes
  • How to support end to end traceability and intelligence across the entire product lifecycle

Register today and see how innovators are showing the industry that taking proactive approaches to quality can have significant business advantages.

Who Will Benefit

  • Quality Affairs
  • Medical Directors
  • Research and Development

This webinar is made possible by PTC and Kalypso.

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Meet Your Presenters


CAPT Sean Boyd

Deputy Director for Regulatory Affairs
CDRH’s Office of Compliance

CAPT Sean M. Boyd serves as the Deputy Director for Regulatory Affairs in the Office of Compliance at FDA’s Center for Devices and Radiological Health (CDRH). In this capacity he is responsible for managing the Center’s quality initiatives, as well as regulatory compliance and enforcement programs for the medical device industry. He has been responsible for all aspects of medical device premarket, postmarket and compliance activities and, prior to joining the Office of Compliance in 2015, led and transformed many aspects of CDRH’s electronic product radiation control program. He is an expert in FDA’s requirements for a variety of consumer, commercial and industrial electronic products, as well as radiation-emitting medical devices.


Daniel R. Matlis


Daniel R. Matlis is Founder and President of Axendia, an analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory matters. Dan has over 25 years of experience in the Industry spanning the entire value chain. He is an active member in FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA.


Francisco (Cisco) Vicenty

Program Manager, Case for Quality
US Food And Drug Administration

Cisco Vicenty is the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients in order to increase focus on the quality and performance of medical devices.