Pre-Conference Workshop:

Developing Your Quality Systems to Incorporate Global Standards

Instructor:
Joe FitzGibbon
President
Orion Canada, Inc.

Workshop Description:

1. Overview of quality assurance/regulatory requirements for selling devices in the US, Europe and Canada.
2. ISO 13485:2003 --- Medical devices --- Quality management systems --- Systems requirements for regulatory purposes --- essential features.
3. Differences between ISO 13485:2003 and ISO 13485:1996.
4. Relationship to ISO 9001:2000.
5. Developing your quality system to incorporate the following:
   • ISO 13485:2003
• ISO 9001:2000
• FDA’s Quality System Regulation
• Europe’s CE Marking requirements
• Canada’s Medical Devices Regulations

(A matrix will be presented, incorporating all of the above)

6. Steps to a successful registration:
• Is it a medical device?
• Classifying Your Device
• Selecting the Registrar
• Quality Manual Structure --- Aligning ISO 13485 & regulatory Requirements
• Additional regulatory procedures
• Setting Quality Objectives and Organizing the Management Review Process
• Technical File
• Use of Harmonized Standards
7. Examples of harmonized standards.
8. Content of the technical file/device master record to satisfy the above jurisdictions.

About the Workshop Instructor
JoeFitzGibbon is president of Orion Canada, Inc.  He assists medical device firms in acquiring ISO 9001, ISO 13485 and EN46001 registration and compliance to FDA's Quality System Regulation, Europe's Council Directive/ 03/43/EEC concerning medical device (CE Marking) and Canada's Medical Devices Regulations.  Mr. FitzGibbon is an IRCA-IQA AMS 2000 Lead Quality auditor (no. A010519) and a qualified medical device auditor.