Understanding 13485:2016 is for anyone in engineering, technical, leadership or management positions in the medical device industry. The 21 CFR 820 FDA regulatory requirements are integrated into this course as they relate to the ISO 13485 requirements. The participants will also learn how the registration process works to help them in the journey towards an ISO 13485 registered quality system. Understanding 13485:2016 is an overview course that will give the participant a general understanding of the requirements of the standard and provide insights into applying the underlying principles of quality management for medical devices in their business. Even if not directly involved in the quality department, engineers and managers can benefit from understanding the requirements of the International Medical Devices Quality Management Systems Standard, ISO 13485. Medical Device manufacturing businesses provide engineers with multiple opportunities including positions as quality engineers, process engineers, managers or other quality professionals. If making payment by Purchase Order or Invoice, please call 1-83. A valid MasterCard, Visa, Discover or American Express credit card will be required for on-line payment.
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