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2019 - The Regulation of in-house IVDs and accreditation of laboratory users in Australia



VenueOnline Event, USA - United States USA - United States

KeywordsLaboratory accreditation; TGA auditing requirements; IVD registration


Topics/Call fo Papers

The definitions of in-house IVDs
The regulatory requirements (including classification and Essential Principles) specific to IVDs
Laboratory accreditation (NATA) requirements related to how and when IVDs can be used as a research or diagnostic tool
Current laboratory supervision requirements for ability to perform and report on in house IVDs
Conformity assessment pathways
TGA auditing requirements
Genetic tests as in-house IVD
Regulation of software as part of in house IVDs

Last modified: 2019-08-22 23:04:14