Originally Published EMDM
March/April 2003
PRODUCT UPDATE
H & W Technology LLCEN- and ISO-compliant machines for use in the validation of biological and chemical indicators, including procedures compliant with EN 867 parts 3 and 4 for the validation of Bowie Dick test packs, are supplied to medical device OEMs.
H & W Technology LLC (Rochester, NY, USA) also provides air overpressure sterilizers and related production units. They can be customized to suit specific customer needs, and unit controls are compliant with 21 CFR Part 11, US FDA’s rule governing electronic signatures and records.
The company also provides consulting services related to 510(k) and PMA submissions, medical device software validation, and steam sterilization quality testing. It serves as the North American representative of a group of testing laboratories located near the University of Tübingen in Germany.
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