ISO 13485:2003 is here and in two and a half years it will be mandatory in numerous countries where many US medical device manufacturers presently market their products. How we approach implementing this new standard will determine whether it is a friend or a foe. We have been taught that change is good, but it is only through experience that we have learned that change often entails a great deal of work.

ISO 13485 represent a major change – a change in concept, being a stand-alone document, and a change in application, pushing the tendrils of quality systems and quality assurance into new area.

This presentation will hopefully serve as a compass, but not a map, to help medical device manufacturers decide how they can adapt their current quality systems that have demonstrated compliance to both the FDA regulations and the demands of the European Union to meet the new challenges and opportunities presented by ISO 13485:2003.

Session Learning Objectives:

• To look back briefly at the past and the history of ISO Quality Management System standards,

• To see an overview of the standard and to discuss of the process approach to quality systems,

• To look at specific areas and functions where the new ISO standard differs or is more proscriptive than the FDA’s Quality System Regulation,

• To examine some implementation and transitions strategies and techniques to help you organize plans to revise, not devise, your current quality system into one that is compliant with all applicable standards and regulations governing the quality systems for medical device manufacturers.

About Our Speaker

Employed in the Medical Device industry since 1976, Rich became involved with the Quality function of manufacturing in 1987, and has worked in Quality, Compliance and Regulatory in a number of start-up medical device companies. He has worked as an employee or consultant for a number of both major and start-up medical device companies.

Rich specializes in assisting start-up, small, and medium sized companies develop quality systems compliant with US and International standards, including achievement of ISO 9001 registration and CE Mark approval for the European Union.

On the regulatory side, Rich has extensive experience in Pre-Market submissions for new products and for clinical evaluations. His successful submissions span many fields of medicine, including such areas as disposable nasal dilators, implantable and disposable prostate and urological devices, tracheotomy devices and a wide range of laparoscopic access and surgical instruments.

A retired US Navy Commander, Rich graduated from the University of California, Berkeley, with a Bachelor of Arts degree and later received a Masters of Business Administration.

He is a co-founder and former Board member of the Orange County Regulatory Affairs Group. He served as the Vice Chair of the Orange Empire Section, American Society for Quality for the 2000-2001 year. In addition he is a Senior Member of ASQ.

Rich is an RAB (Certificate #Q07716) and ASQ (Certificate #16298) Certified Quality Auditor.