Risk Management in IEC 60601-1 Third Edition - Webinar by GlobalCOmpliancePanel

October 25, 2010

GlobalCompliancePanel, USA
2010-11-11

This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be withdrawn. Devices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the requirements of the new standard.

Areas Covered in the Session:

ISO 14971 compliance is a requirement of IEC 60601-1
The new standard uses risk management throughout
The new standard is less prescriptive in many areas
The new standard requires that all applicable collateral and particular standards must be used for compliance
Current activities leading to full implementation of the standard
Available documents to guide implementation of the Third Edition

Who Will Benefit:

Design Engineers
Quality Engineers and Managers
Compliance Engineers
Engineering Managers
Project Managers
Verification and Validation Engineers and Mangers

Organized by:

GlobalCompliancePanel

Invited Speakers:

Edwin L Bills: - During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.

Deadline for Abstracts:

2010-12-09

Registration:

Thursday, November 11, 2010
10:00 AM PDT | 01:00 PM EDT

Live live online training only for one participant

Price: $245.00

Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)

Price: $995.00

E-mail:

webinars@GlobalCompliancePanel.com