Device Design and Risk Management

Thursday, June 22, 2017 · 1:30 p.m. - 3:00 p.m. EDT

Medical device design is linked inextricably with risk management. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too.

Governing it all is an alphabet-soup of Quality Management Systems (QMS) provisions including ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, and EN ISO 13485:2016, as well as risk management requirements in the common Risk Management Systems (RMS): ISO 14971:2007 and EN ISO 14971:2012.

Register now for a study-up session with a leading authority on in quality, operations, and program management in medical device design and manufacture.

Dan O’Leary of Ombu Enterprises has a long track record training operations management professionals via a unique systems approach perfected over 30 years of training. In 90 fast-paced minutes, he’ll cover a lot of ground:

  • 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.

Better design and smoother operations benefit everyone — your employer, your customers, maybe your paycheck too. It’s well worth 90 minutes out of your week to sharpen skills and increase professional standing. Register now.

Webinar plus Audio CD/Transcript
Learn more


add to cart

Webinar only
Learn more


add to cart

24/7 Encore plus Audio CD/Transcript
Learn more


add to cart

24/7 Encore Presentation
Learn more


add to cart

Audio CD/Transcript
Learn more


add to cart


Who Will Benefit

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



Meet Your Presenters

Dan O’Leary

Ombu Enterprises LLC

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.

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

Phone (703) 538-7600 | Fax (703) 538-7676 | Toll free (888) 838-5578 | Email

© 2017 FDAnews