Arkray Factory, Inc. - Oct. 8, 2014
Issue Date
Oct 08, 2014
Region
HQ
Category
Device
$117.00
Contact Name
Masanori Hatta
Contact Title
President and Chief Executive Officer
Address 1
1480 Koji
Address 2
Konan-Cho
State
Koka-Shi
Zip/Postal Code
520 3306
Country
Japan
Inspection Range
Oct 06, 2014 - Oct 08, 2014
Pages
3
First Observation
The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
Investigator(s): Catherine J. Laufmann