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Enjoying the Summer!

ISO 13485:2003 - Implement & Maintain

Date: Tuesday, July 22, 2008

Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA

Overview:
Medical Device sales in Europe, Canada, and numerous other countries require medical device manufacturers to demonstrate compliance to the ISO 13485 Quality System Standard. Companies wanting to sell or those already selling medical devices in either of these locations should have a registered ISO 13485 quality system in place. Companies that already have ISO 13485 registered must now be prepared for their Notified Body's annual surveillance audit. Companies will want to ensure that they maintain compliance to ISO 13485:2003 as their CE Marks, and therefore the ability to sell product internationally, will be at risk. Employee training is a compliance requirement of ISO 13485:2003. This course will help meet these requirements and will provide an understanding of the standard and its relationship to FDA's Quality System Regulation. ISO 13485, entitled "Medical Devices-Quality Management Systems-Systems Requirements for Regulatory Purposes", is a key element to the global harmonization of medical device manufacturing quality systems worldwide. The vast majority of medical device manufacturers will want to embrace and implement ISO 13485 as soon as possible in order to meet the regulatory requirements of numerous countries worldwide. This course will explain ISO 13485 and how to implement it along with FDA's Quality System Regulation (QSR, 21 CFR Part 820) such that a manufacturer will be able to efficiently implement and maintain compliance with both systems. Attendees will be able to strategically assess their company's global quality system requirements and implement or maintain a matching quality system accordingly. Attendence will be especially beneficial to Executive management, middle management, supervisors, and front line employees of all departments within an organization. Personnel and inter-departmental teams attending from departments such as Quality, Regulatory, R&D, Manufacturing, Production, Service, Return Goods, Documentation, Executive Management, Purchasing, and Sales Departments will gain special benefit by understanding the implementation and maintenance requirements for compliance to ISO 13485.

What you will learn:

• The detailed elements of the ISO 13485:2003 standard
  
• Brief History and Rationale for ISO 13485
  
• Key factors in implementing and maintaining compliance
  
• Understanding of the key differences between ISO 13485, FDA QSR/GMP and ISO 9001
• Strategies for streamlining implementation
• Impact of ISO 13485 internationally, including Europe (EC), Canada, Japan, and Australia
  
• How ISO 13485 will affect your CE Mark and International Sales.
  
• What, when, and how will Notified Bodies inspect now and in the future
  

Benefits of Attending:

• Company preparation for ISO 13485 registration or Notified Body annual surveillance audit
  
• Access or continued sales in numerous international markets
  
• Compliance with ISO 13485 requirement for employee training
  
• Assist with the maintenance or creation of a compliant ISO 13485 Quality System
  
• Help to create an efficient Quality System that meets both FDA QSR & ISO 13485, and Canada CMDCAS
  
• Gain an international perspective of ISO 13485 and its transition
• Plan for new CE Mark approvals or maintenance of your current CE Mark
  
• Understand the need for risk managment and ISO 13485
  
• Solidify your company's global quality system strategy

Abbreviated Outline:

• A. Brief History and Rationale for the ISO 13485
  
• B. Why ISO 13485 implementation is important
  
• C. Process vs. Procedural approach
  
• D. ISO 13485 Elements
  
• E. Key Differences of ISO 13485 and FDA Quality System Regulation
  
• F. Key Differences of ISO 13485 and ISO 9001
• G. Implementation strategies & TR 14969
• H. Implementing multiple quality systems efficiently
• I. CE Mark and transition issues
• J. Risk Managment and ISO 13485 Quality Systems
• K. Global Strategies and Recommendations for Manufacturers
  
• L. Summary & Review
  

Speakers: Ray Pizinger, Rich Basler

Ray Pizinger & Rich Basler co-authored a two part article discussing ISO 13485 that appeared in Medical Product Outsourcing:

Jan/Feb 2004 Article Part 1 "The Arrival of ISO 13485:2003" (172 KB)

Mar/April 2004 Article Part 2 "Implementing ISO 13485:2003" (138 KB)

Registration & Additional Information : Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.

On-line Registration Form Register on-line to reserve your seat now!