Device manufacturers who want to reach world markets are faced with a plethora of regulatory schemes that appear to be disjointed and unconnected.

Although, at first glance, this may be true, there are some harmonizing influences afoot that wise manufacturers can take advantage of in marketing their products across the globe. The audioconference with explore these possibilities.

This audioconference will cover:

Differences in regulation among the major device markets

Similarities in regulatory approaches that now exist

Harmonizing influences

Three standards that can help you get to where you want to go

About the speaker:

Dr. Harvey 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 working for 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?

CEOs

Senior Managers

QA Directors

Regulatory Affairs Directors

This audio conference is rated General Interest.