FDAnews Announces — Biocompatibility for Medical Devices Webinar, April 20, 2017

Share Article

FDA and EU inspectors will sanction manufacturers for medical devices that flunk biocompatibility standards. Untangle their complexities in 90 minutes.

Biocompatibility for Medical Devices
**An FDAnews Webinar**
April 20, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/biocompatibilitymd                

ISO 10993-1:2009 ... EN ISO 114971:2012 ... ISO 14971:2007 ... ISO/TR 15499:2016. The names alone could give device manufacturers a headache.

Now try figuring out what it all means.

Manufacturers need to, if their medical devices are to pass FDA and EU muster and avoid warning letters. Spend 90 productive minutes with a leading expert on regulation demystification who’ll clarify all the complexities, including:

  • How biocompatibility fits into the risk management process
  • Additional burdens the EU piles on
  • Line-by-line explanation of that alphabet-soup of ISOs
  • And much more

SPECIAL BONUS: Activity analysis explaining actions needed to integrate biocompatibility into the risk management framework.

Patient safety is the bottom line. Why risk warning letters, liability or lawsuits when help is as close as the screen on a desktop?

Register today and put products on a sounder regulatory footing.

Meet the Presenter:
Dan O’Leary, Ombu Enterprises LLC. For more than 30 years, Mr. O’Leary has been practicing or training others in quality, operations and program management in regulated industries. He has developed a systems approach to operations management that reduces arcane regulatory concepts into everyday language. A Six Sigma Black Belt, he is an ASQ-certified biomedical auditor and is certified by APICS in resource management.

Who Will Benefit:
Both risk management and biocompatibility start with device design but continue through production and post-production information collection and evaluation. People who will particularly benefit from this presentation include:

  • Design Engineering Managers
  • Design Project Leaders
  • Design Engineers
  • Risk Managers
  • Risk Management Professionals
  • Biocompatibility Scientists And Engineers
  • Complaint Information Analysts
  • Data Analysts

Webinar Details:
Biocompatibility for Medical Devices
**An FDAnews Webinar**
April 20, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/biocompatibilitymd                

Tuition:
$287 per site

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

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website