Introduction to ISO 13485 Quality Management System for Medical Devices

Home
About Us | Contact
Editorial Guidelines | Training Calendar

0 item(s) | Shopping Cart | Wish List

E-mail this product to a friend

ON-DEMAND WEBINAR
Access Anytime!

Access the recorded version of this webinar anytime from any computer. Attend when it's most convenient for you. You can access the webinar as often as you like from any location for ONE FULL YEAR from the date of registration.

SUMMARY
This is a no-miss presentation is for any manufacturer or distributor of medical or dental device products looking to opportunities beyond U.S. borders. It provides the participant with an in-depth introduction to the international standard for medical devices. Many countries including all EU member states, Canada, Japan and Australia require registration to ISO 13485:2003 in addition to demonstrated compliance with other regulatory requirements issued by country or union. This training is intended for individuals within a medical device manufacturing firms responsible for implementation,coordination and management of company quality management system with either impending or ongoing registration to ISO 13485:2003.

INSTRUCTOR:
John Dahlgren (click for instructor profile)

LENGTH

Two Hours

PRICE

$359

WHY TAKE THIS COURSE?
After viewing this webinar you will understand:

The difference between ISO 13485:2003 and previous versions of medical device quality standards (ISO 9001:1994 + ISO 13485:1996)
The interactions of each of the primary clauses in the process-based quality system
The stand-alone requirements of each of the primary clauses in the process-based quality system
The basis of a quality manual in a process-based quality system as a means to develop quality objectives
The interactions between ISO 13485:2003 Quality Management System and medical device regulations

WHO SHOULD VIEW THIS WEBINAR

Individuals responsible for and who interact with a medical device quality management system
Quality and regulatory professionals including: Managers, Directors, Audit team members
Upon entering the course it is recommended that the webinar attendee is familiar with the ISO 13485:2003 Medical Device Quality Management System and Medical Device Regulations – FDA QSR, MDD, CMDR and JPAL

COURSE OUTLINE

An overview of the process-based quality standard
ISO 13485:2003 overview by process elements:

Clauses 1, 2, 3 and 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis and Improvement

A dive into each of the above clauses, their interactions and stand-alone requirements
An overview of medical device regulation and interaction with the ISO standard

HOW DOES THIS ALL WORK?
After you register for the webinar, you will receive a confirmation e-mail. It will contain a Web link to access the recorded webinar through your Web browser. You can access the recorded webinar for one full year from the date of your registration. You will need the link that will be e-mailed to you each time you wish to access the webinar.

PLEASE NOTE: The link to access the webinar will be e-mailed to you immediately after you register. If you do not receive the link, please check your spam or junk mail folder.

Price: $359.00


The CE Mark: Understanding the Medical Device Directives	The Regulatory Compliance Almanac	Introduction to ISO 13485 Quality Management System for Medical Devices	Project Management in a Quality Management System

The CE Mark: Understanding the Medical Device Directives
$34.95

The Regulatory Compliance Almanac
$99.00