Complianceonline, Online Web Event
2010-04-20
This medical device training on International Standards will address various sources of external standards, how they are developed and the differences from region to region. Why Should You Attend: Understanding where to obtain the correct and current versions of international standards and guidance documents is crucial to properly designing, testing and obtaining approval for medical devices. A medical device manufacturer who wishes to market their device must know how to determine the applicable standards and insure that the current version is available. The same standards are available from multiple sources under different designations. Is an ISO standard the same as the EN ISO version and what about the BS EN ISO version? Are all of them needed? This seminar will help you understand the alphabet soup of standards. Device approval, especially outside the US is driven by conformance to ISO, IEC and other standards. A device manufacturer must how to determine the applicable standards and guidance documents, keep them current and be on the watch for new ones. The presentation addresses the various sources of external standards, how they are developed and the differences from region to region. Examples and links to the various web sites is provided. Areas Covered in the Seminar: - Sources of external standards / documents.
- Standards Bodies – ISO, CEN, AAMI, etc
- Regulations – FDA, MDD, CMDR
- ISO, EN, BS EN, AAMI/ANSI – making sense of the standards alphabet soup.
- Harmonized Standards – Source, meaning, updates.
- Third Party sources of standards, ILI, BSI, etc.
- Keeping up to date.
- Requirements, resources, transition periods
- Copyrights, filing, what standards do you need to have.
- Discussion: Examples @ contractors, customers, etc.
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