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Updated in [July 24th, 2023]

This course provides an overview of the ISO 13485 standard, which is an international standard for medical device quality management systems. It covers the requirements of the standard, the benefits of implementing it, and the steps necessary to achieve certification. The course also provides an overview of the regulatory environment for medical devices, and the implications of the standard for medical device manufacturers. The course is designed to provide an understanding of the ISO 13485 standard and its requirements, and to provide an overview of the regulatory environment for medical devices. It is intended for those who are involved in the design, development, manufacture, and/or distribution of medical devices, and who need to understand the requirements of the standard and the implications for their business. The course will cover the following topics: • Overview of the ISO 13485 standard • Benefits of implementing the standard • Steps necessary to achieve certification • Regulatory environment for medical devices • Implications of the standard for medical device manufacturers At the end of the course, participants will have a better understanding of the ISO 13485 standard and its requirements, and will be able to identify the steps necessary to achieve certification. They will also have an understanding of the regulatory environment for medical devices, and the implications of the standard for medical device manufacturers. This course is ideal for those who are involved in the design, development, manufacture, and/or distribution of medical devices, and who need to understand the requirements of the ISO 13485 standard and the implications for their business. It is also suitable for those who are interested in learning more about the regulatory environment for medical devices and the implications of the standard for medical device manufacturers.