Audio Conference

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices Harvey Rudolph, PhD Global Program Manager, Medical Devices Underwriters Laboratories Purchase recording - US$199

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The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.

Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.

This audio conference will examine how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.

This audio conference will address:

• The need for risk management in designing to the 3rd edition
• Documentation necessary for the certifier
• The necessary change in perspective for both manufacturers and certifiers in certifying to the 3rd edition
• The need for determining levels of risk acceptability

Speaker biography:

Dr. Rudolph's work at UL involves developing a global regulatory conformity assessment program as well as new regulatory services. As part of these duties, he represents UL to medical device regulatory agencies. He is also in charge of developing external and internal training programs and provides oversight for UL regulatory accreditations.

Prior to joining UL, he worked for the Food and Drug Administration for 25 years, serving in a wide variety of regulatory roles, including the establishment of the accredited persons program for 510(k) review, the recognition of consensus standards for satisfying regulatory requirements, and the evolution of FDA's software policy.

While at FDA, Dr. Rudolph played a key role in writing several guidance documents. He has served on the ISO/IEC Joint Working Group for Risk Management, since its inception, and co-chairs the US Technical Advisory Group.

Who Should Attend?

• Quality Assurance/Control
• R&D engineers
• Product design engineers
• Compliance engineers
• Regulatory Affairs
  
  This audio conference is rated General Interest.
  

Purchase Options:

• Purchase a recording of this event US$199