The International Quality System for Medical Devices

The International Quality System for Medical Devices
Transitioning to ISO 13485 / 2003
The International Quality System for Medical Devices
Feb. 24-25, 2003
Ft. Lauderdale, FL
See Below

Guest Speakers:

This two-day conference will address how and why ISO 13485 came to pass, its key elements and the impact it may have on your business and the Medical Device and Diagnostic industry. You will walk away with a clear understanding of the requirements you will need to meet for a Quality System that meets both the revised ISO 13485 and the FDA QS Regulation.

Attendance is a must for anyone responsible for assuring that your company is prepared for and stays in compliance with US and International Regulations. You’ll take home working examples of how to implement a Quality System that complies with both ISO 13485/2003 and the FDA QS regulation.

Day 1
Keynote presentation: What is ISO 13485/2003 and how does it affect you?
Why it exists, what’s its purpose and its key elements
How ISO 13485 fits with European CE Marking Regulations
Global Implications of ISO 13485
Should medical devices manufacturers meet ISO 9001:2000?
Open Q&A with Notified Body & FDA
Day 2
How to construct a Quality System that meets both ISO 13485 and the QSr (1/2 day)
Contrast of Audit Techniques between a Notified Body Auditor and a FDA Inspector
Comments on Establishment Inspections by Accredited Persons (third parties) per P.L. 107-250
The Medical Device User Fee and Modernization Act of 2002
Update on the Global Harmonization Task Force
Download registration form in PDF (requires Adobe Acrobat Reader)

Registration information:

ASQ Members Non-Members
Full Conference: $675 $850
Day 1 or Day 2: $475 $650
Continental breakfast, all breaks, lunch and networking session included in registration fee.

Download the registration form or contact Kelly Blakley at (800) 492-6961 to register. Company or personal check payable to "ASQ Biomedical". MasterCard or VISA are accepted. Attendance is limited and pre-registration is required; walk-ins will not be accepted.
Confirmation is not provided, but you will be notified if the seminar is oversubscribed.

Conference Location and Hotel Information:

The conference is being held at the:

    Fort Lauderdale Marriott North Hotel
    6650 North Andrews Ave.
    Fort Lauderdale, FL 33309

ASQ Biomedical has block booked a limited number of rooms at a special discount rate of $139.00 per night at the Fort Lauderdale Marriott North Hotel. Call 800-343-2459 to make your reservation and make sure to mention that you are attending the American Society for Quality- Biomedical Division conference.

ASQ Biomedical has negotiated a flat rate for your transportation to and from the Ft Lauderdale International Airport with Coastal Limousine Service. Parties of up to 4 people can get a Town Car for $35.00 each way and parties of up to 10 people can get a van for $70.00 each way. Standard Cab fare averages $30 each way. Call toll-free 800-771-7493 for Coastal Limousine and make sure to tell them you are attending the American Society for Quality-Biomedical Division conference.

Conference attendees are responsible for making their own hotel reservations along with transportation to and from the hotel.

Further information:

Email David Leo or call 413-596-2883.