Overview of ISO 13485 – as needed for European and Canadian Marketing of Medical Devices

Description:

This seminar will explain what ISO 13485 is and why it is important for medical device and diagnostic companies who design or produce devices. It will give a basic overview of the requirements of ISO 13485, Medical Device - Quality Management Systems - System Requirements for regulatory purposes. It will discuss you become compliant to ISO 13485, as well as how to begin the process of being certified to ISO 13485.

Course Objective:

Many people in the medical device industry do not know much more about quality systems than that they are required. This seminar provides an overview of medical device quality systems and then describes generally the requirements of the ISO 13485 international standard for medical devices quality management systems (QMS). Medical devices can be simple or complex, but all of these can benefit from being designed and manufactured under ISO 13485 which is the most widely used medical device QMS standard. It is required for most devices sold in Europe, Canada and many other countries.

Course Outline:

• What is ISO 13485
• When and why to you need to be ISO 1345 certified
• Requirements of ISO 13485
• Management responsibility
• Customer requirements and feed back
• Design Controls
• Risk Management

Target Audience:

This webinar will provide valuable assistance to all personnel new to Medical Devices or ISO13485 and are involved in:

• Quality Management
• Quality auditing
• Supplier Auditing

Speaker Profile : Betty Lane

Betty Lane, has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements.

Webinar Price Tags :

$ 209.00 Single Attendee

$ 749.00 Group – Max 10 Attendees per location

$ 259.00 Access Recorded Version online

$ 349.00 Buy Training CD-DVD

For More Details or Enrollment Or Registration :

Contact : complianzworld

Phone : +1-866-978-0800

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E-mail ID : webinarhelp@complianzworld.com