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2019 - The Regulation of in-house IVDs and accreditation of laboratory users in Australia
Date2019-09-25
Deadline2019-09-25
VenueOnline Event, 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
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
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Last modified: 2019-08-22 23:04:14