Medical Devices 2011 - Introduction to ISO 13485 Quality Management System for Medical Devices

Why You Should Attend:
All EU member states and satellite countries, Canada, Japan and Australia, require registration to ISO 13485 to sell your medical devices. Development and implementation of a quality system that is compliant with ISO 13485 requires many resources and personnel. ISO 13485 is a wordy standard, drafted by individuals for many of whom English is not their primary language! This webinar provides a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system.

Areas Covered in the Seminar:

What is ISO 13485, and what does a company need to do to Register to ISO 13485?
Purpose and structure of ISO 13485.
Systemic Requirements.
Management Requirements.
Resource Requirements.
Realization Requirements.
Remedial Requirements.
Implementation of an ISO 13485-compliant quality system.