FDAnews Announces — Driving a Culture of Change for Devicemakers Webinar, Sponsored by Axendia, March 1, 2017

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. Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco Vicenty — Mechanical Engineer, 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.

Falls Church, VA (PRWEB) February 17, 2017

Driving a Culture of Change for Devicemakers

Sponsored by Axendia

**FDAnews Free Webinar**

March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET

http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers

Are manufacturers looking to reduce their 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 — Mechanical Engineer, 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.

Attendees 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 the 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.

This webinar is made possible by PTC and Kalypso.

Meet the 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, President, Axendia:

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,Mechanical Engineer, US Food And Drug Administration:

Cisco Vicenty is a Mechanical Engineer at US Food And Drug Administration. He is also currently 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.

Who Will Benefit:

  •     Quality Affairs
  •     Medical Directors
  •     Research and Development

Webinar Details:

Driving a Culture of Change for Devicemakers

Sponsored by Axendia

**FDAnews Free Webinar**

March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET

http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers

Easy Ways to Register:

Online:     http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/cultureofchangedevice/prweb14080949.htm

FDAnews Announces — Driving a Culture of Change for Devicemakers Webinar, Sponsored by Axendia, March 1, 2017

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. Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco Vicenty — Mechanical Engineer, 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.

Falls Church, VA (PRWEB) February 17, 2017

Driving a Culture of Change for Devicemakers

Sponsored by Axendia

**FDAnews Free Webinar**

March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET

http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers

Are manufacturers looking to reduce their 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 — Mechanical Engineer, 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.

Attendees 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 the 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.

This webinar is made possible by PTC and Kalypso.

Meet the 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, President, Axendia:

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,Mechanical Engineer, US Food And Drug Administration:

Cisco Vicenty is a Mechanical Engineer at US Food And Drug Administration. He is also currently 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.

Who Will Benefit:

  •     Quality Affairs
  •     Medical Directors
  •     Research and Development

Webinar Details:

Driving a Culture of Change for Devicemakers

Sponsored by Axendia

**FDAnews Free Webinar**

March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET

http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers

Easy Ways to Register:

Online:     http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/cultureofchangedevice/prweb14080949.htm