Bioptron AG - Nov. 11, 2017
Issue Date
Nov 01, 2017
Region
HQ
Category
Device
$117.00
Contact Name
Vincent O. Auberson
Contact Title
General Manager
Address 1
Gouttes dor 30
City
Neuchatel
Zip/Postal Code
CH-2008
Country
Switzerland
Inspection Range
Nov 01, 2017 - Nov 01, 2017
Pages
4
First Observation
Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
Investigator(s): Catherine J. Laufmann