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UNDERSTANDING ISO 13485:2003 QUALITY STANDARD FOR MEDICAL DEVICES INDUSTRY (COURSE CODE:IS/10)
Course Objective & Benefit
This program is designed to provide attendees with the tools and knowledge necessary to upgrade their quality system to an international recognized medical device standard. In addition to providing the latest requirement for compliance with the standard, attendees will learn how to prepare, manage and successfully complete an inspection by the certification bodies.
Course Outline
Personnel attending this program will have an opportunity to learn how to prepare for an ISO 13485 audit, what to expect during interaction with auditors and how to respond to the findings. Additionally this course is a good refresher for all personnel involved in the medical device business and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format.
Who Should Attend
This course is directed toward those who are responsible for research, development, manufacture, marketing, quality, and/or regulatory compliance within the medical device industries. The course will benefit individuals whose job functions include operations governed or overseen by various regulations including personnel involved in preparing for, participating in and responding to medical device inspections
About the Facilitator
The tutor is registered ISO 13485 Lead Auditor, CMDCAS Auditor, JPAL Auditor.
He has audited over 50 organizations on Medical Device Certification.
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