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UNDERSTANDING ISO 13485:2003 QUALITY STANDARD FOR THE MEDICAL DEVICES INDUSTRY TRAINING (CPD1018) 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. Objective 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. Certification A certificate of attendance (issued by SGS Hong Kong Ltd.) will be presented to all delegates ** This training course is only suitable for HKIE members. |
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