---

Enjoying the Summer!

ISO 13485:2003 - Implement & Maintain

Date: Tuesday, July 17, 2007

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

Overview:
 The deadline to transition to ISO 13485:2003 has passed in both Europe and Canada. Companies wanting to sell or those already selling medical devices in either of these locations should have a registered ISO 13485:2003 quality system in place. Companies that have ISO 13485:2003 registered must now be prepared for their Notified Body's annual surveillance audit. Companies that already have ISO 13485:2003 in place 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 this requirement and will provide an understanding of the standard and its relationship to FDA's Quality System Regulation. ISO 13485:2003, 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 13485:2003 as soon as possible in order to meet the regulatory requirements of numerous countries worldwide; e.g. This course will explain ISO 13485:2003 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 13485:2003.

What you will learn:

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

Benefits of Attending:

• Company preparation for ISO 13485:20003 registration or Notified Body annual surveillance audit
  
• Access or continued sales in numerous international markets
  
• Compliance with ISO 13485:2003 requirement for employee training
  
• Assist with the maintenance or creation of a compliant ISO 13485:2003 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 13485:2003 and its transition
• Plan for new CE Mark approvals or maintenance of your current CE Mark
  
• Understand the need for risk managment and ISO 13485:2003
  
• Solidify your company's global quality system strategy

Abbreviated Outline:

• A. Brief History and Rationale for the ISO 13485:2003
  
• B. Why ISO 13485:2003 implementation is important
  
• C. Process vs. Procedural approach
  
• D. ISO 13485:2003 Elements
  
• E. Key Differences of ISO 13485:2003 and FDA Quality System Regulation
  
• F. Key Differences of ISO 13485:2003 and ISO 9001:2000
• G. Implementation strategies & TR 14969
• H. Implementing multiple quality systems efficiently
• I. CE Mark and transition issues
• J. Risk Managment and ISO 13485:2003 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 13485:2003 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!