Meluna - Nov. 9, 2017
Issue Date
Nov 09, 2017
Region
HQ
Category
Device
$117.00
Contact Name
Frank Krueger
Contact Title
Owner and Chief Executive Officer
Address 1
Brand 57
City
Haundorf, Bayern
Zip/Postal Code
91729
Country
Germany
Inspection Range
Nov 06, 2017 - Nov 09, 2017
Pages
6
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): Catherine J. Laufmann