MEDICAL DEVICES 2010 - Introduction to ISO 13485 Quality Management System for Medical Devices - Medical Devices webinar By ComplianceOnline

Website http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=701790?channel=ourglocal | Edit Freely

Category Medical Devices,conference,event,Webinar

Deadline: December 21, 2010 | Date: December 21, 2010

Venue/Country: Palo Alto, U.S.A

Updated: 2010-12-03 18:02:09 (GMT+9)

Call For Papers - CFP

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.