Clinical Evaluations – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Fri, 28 Jan 2011 12:00:50 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Clinical Evaluations – Eisner Safety Consultants https://eisnersafety.com 32 32 Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed. https://eisnersafety.com/2011/01/28/leo-eisner-presenting-at-raps-asq-on-iec60601-1-3rd-ed/?utm_source=rss&utm_medium=rss&utm_campaign=leo-eisner-presenting-at-raps-asq-on-iec60601-1-3rd-ed Fri, 28 Jan 2011 12:00:50 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2003  


Biomedical Division Northern California Discussion Group  andSan 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

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