V22A_25- Understanding ISO 13485: Medical Device Quality Management Systems
Self-paced
0.2 credits
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Full course description
Welcome to Understanding ISO 13485: Medical Device Quality Management Systems! Medical Device manufacturing businesses provide engineers with multiple opportunities including positions as quality engineers, process engineers, managers or other quality professionals. 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. 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. The participants will also learn how the registration process works to help them in the journey towards an ISO 13485 registered quality system. The 21 CFR 820 FDA regulatory requirements are integrated into this course as they relate to the ISO 13485 requirements. Understanding 13485:2016 is for anyone in engineering, technical, leadership or management positions in the medical device industry. It can be especially beneficial to those who are responsible for quality, quality management, regulatory compliance and/or process improvement. The international quality management system standard, ISO 13485, is the basis for an effective quality system for any business in the medical device industry. This standard is recognized worldwide and provides a ‘road map’ for a quality system that can be tailored to your business. Your medical device quality system should be the way ‘the work gets done’; be easy to maintain; be user friendly; and provide significant internal benefits while facilitating regulatory compliance to both the EU Medical Device Regulation and the 21CFR 820 FDA requirements.