Importance of Technical Standards in the Medical Device Sector
This course examines what technical standards are, the process of creating them, and the rationale for knowing such information.
Practitioners of standards often use highly specialized terminology to describe what is, in reality, fairly straightforward. This course focuses on the standards developed by two international organizations who specialize in the medical device field: ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission).
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Upon successfully completing this course, trainees will be able to:
- Define what a technical standard is
- Recognize the terminology that practitioners of standards use
- Identify the basic process of creating a standard, from initial concept to published document
- Explain the importance of standards and the standardization process
R&D engineers, regulatory affairs associates, quality assurance associates, and administration in the aforementioned fields are welcome to enroll in this course.
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.