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Risk, Compliance and Quality Assurance:
Does Your Company Have the
Internal Expertise?
Wednesday, February 15
7:30 AM - 9:00 AM
Peabody Marriott
Cost: $25 for NSTC members, $40 for non-members
Because there is a limited capacity for this event, we recommend advanced
registration. Register online now
and reserve your seat today!
Program Description:
Manufacturing technology products requires a well-defined and documented quality
assurance process to not only mitigate risk, but to control costs and navigate any regulatory bureaucracy.
Does your product meet every regulatory requirement of each country you're selling in? How well can you
identify potential risks and meet regulatory compliance standards of IEC, ISO, DIN, ANSI and others?
An internal quality practice including compliance and testing should be universal for all of your products.
In particular, highly sophisticated products such as medical applications will encounter scrutiny from such
government entities as the FDA about the product behavior, safety, and effectiveness.
How do you choose which products for development? What are the engineering issues? How will product updates
affect your reputation? How do you capitalize on interdepartmental research and resources?
Learn from two leading industry experts about how to identify the risks and complexities of a proper
quality assurance program.
About the Speakers:
Bill Bolt, ABIOMED senior vice president for global quality and services,
has been responsible for all quality and design assurance since January 2003 and added the service
organization in spring 2005. From 1999-2002, he was senior vice president of product development where
he was responsible for all product development.
During this time he led the AbioCor Artificial Heart
program from 2000-2002, and was responsible for all other cardiac systems development from 1999-2002.
From 1994 to 1998, he was president of ABIOMED's dental subsidiary, ABIODENT. From 1982, when he joined
the company, to 1994, he served in various roles from vice president of engineering to vice president
of operations, where he was the engineer-in-charge of the development of the BVS and other systems.
Mr. Bolt received his Bachelor's degree in electrical engineering and an MBA from Northeastern University.
ABIOMED was founded more than two decades ago with a singular mission - to make real the day when heart
failure need not mean the end of life or the ability to enjoy life. The company develops, manufactures
and markets innovative heart assist and replacement systems.
Bob French, Analogic Corporation's vice president of corporate quality assurance and regulatory affairs
since 1987, joined the company in 1979. He is responsible for establishing and maintaining the corporate
quality system and developing the expertise for the corporation to stay in compliance with domestic and
international standards and directives.
Mr. French's executive expertise is in the strategic development, growth and running of P&L and cost centers,
QA/RA systems and service and support of the corporate products.
Analogic Corporation is an OEM supplier of complete systems and advance subsystems for security and medical
imaging, including computed tomography, magnetic resonance imaging, digital radiography, ultrasound,
and patient monitoring applications.
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