Importance of Technical Standards in the Medical Device Sector
For many of us, it may seem quite mysterious and obscure what a standard is or where it comes from and how they are created. However - as is often the case, the practitioners of standards use a quantity of highly specialized terminology to describe what is in reality a fairly straightforward process. This course examines what is a standard, the process for creating standards and the rationale as to why you should know this information.
The focus of this course will be on standards developed by two international organizations that do a good deal of work in the medical device area: ISO (International Organization for Standardization) and the IEC (International Electrotechnical Commission).
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Upon completion of this course, trainees will be able to correctly and successfully:
- Define what a standard is
- Recognize the terminology that practitioners of standards use
- Identify the basic process steps that most standards follow, from initial concept to published document
- Explain why you should care about standards and the standardization process
Engineers, R&D, RA Associates, QA Associates, Administration in R&D/RA/QA.