FDAnews Announces — Device Design and Risk Management Webinar, June 22, 2017

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Those that have been involved in design of medical devices for any length of realize that risk management is an integral aspect of the work. Better design and smoother operations benefit everyone.

FDAnews

FDAnews

Device Design and Risk Management
**An FDAnews Webinar**
June 22, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/devicedesign

Those that have been involved in design of medical devices for any length of realize that risk management is an integral aspect of the work.

Indeed, the two processes are intertwined. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too.

Governing both is a forest of rules: ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, and EN ISO 13485:2016 on the QMS side ... ISO 14971:2007 and EN ISO 14971:2012 affecting RMS.

Mark the calendar for Thursday, June 22, when noted operations management guru Dan O’Leary and FDAnews present the training session manufacturers have been hoping for.

Get set for an intense hour and a half of knowledge and skill building:

  •     Overview: Design control from the risk management perspective
  •     Overview: Risk management from the design control perspective
  •     When, where and how the two system interact
  •     Recognizing when requirements of the one system support/complement requirements of the other
  •     Using product safety standards to improve design control and risk management efficiency
  •     And much more!

Bonus! A chart showing relationships between the clauses of EN ISO 13485:2012 and EN ISO 14971:2012.

Professional development requires constant brushing up. Get the training needed easily, quickly and at reasonable expense. Sign up now.

Meet the Presenter:
Dan O’Leary is President of Ombu Enterprises LLC, a consultancy offering training and execution in Operational Excellence. Based on more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs, Mr. O’Leary has developed a unique systems approach to operations management that has benefited thousands of devicemakers. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer and Reliability Engineer and holds the Six Sigma Black Belt. He is APICS-certified in Resource Management.

Who Will Benefit:

  •     Quality Managers
  •     Design Engineers
  •     Production Managers involved in process changes
  •     Quality Engineers
  •     Manufacturing Engineers
  •     Regulatory Affairs
  •     Risk Managers

Webinar Details:
Device Design and Risk Management
**An FDAnews Webinar**
June 22, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/devicedesign                        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/devicedesign                                                                                        
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.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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