Materialise USA, LLC - April 26, 2011
Issue Date
Apr 26, 2011
Region
Central
Category
Device
$117.00
Address 1
44650 Helm Ct.
City
Plymouth
State
MI
Zip/Postal Code
48170-6061
Country
US
Inspection Range
Apr 06, 2011 - Apr 26, 2011
Pages
4
First Observation
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system; procedures for quality audits have not been adequately established; written MDR procedures have not been developed.
Investigator(s): Ryan J. Benedict and Bleta Vuniqi