Biomedical Division Northern California Discussion Group and
San Francisco Bay Area Chapter
Topic: “Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas:
- IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry
- Usability and Human Factors verification, validation, and regulatory requirements
- Clinical evaluation and investigation regulatory requirements
Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Geetha Rao, PhD, VP, risk management and strategy, Triple Ring Technologies, Inc; Ibim Tariah, technical director, BSI Healthcare; Craig J. Coombs, RAC, president, Coombs Medical Device Consulting, Inc.; and Juergen Stetin, president and CEO, PROSYSTEM AG
When: March 4, 2011 (Friday), presentations start right at 8:30AM check-in 7:45AM with Continental Breakfast
Registration Contact: Wesley Carr or call +1 301-770-2920 ext. 231 Registration form for event, must register by Feb 25, 2011, space is limited
Where: Crown Plaza Mid-Penisula, 1221 Chess Drive Foster City, CA 94404