Somatex Medical Technologies GmbH - Oct. 16, 2014
Issue Date
Oct 16, 2014
Region
HQ
Category
Device
$117.00
Contact Name
Frank Kneip
Contact Title
Managing Director
Address 1
Rheinstrasse 7 d
City
Teltow
Zip/Postal Code
14513
Country
Germany
Inspection Range
Oct 13, 2014 - Oct 16, 2014
Pages
4
First Observation
The written MDR procedure does not include an internal system which provides for the timely and effective identification, communication, and evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Roy Baby