Turon Medtech AB - June 2, 2016
Issue Date
Jun 02, 2016
Region
HQ
Category
Device
$117.00
Contact Name
Goran K. Ekstrom
Contact Title
Co-Owner
Address 1
Kardanvagen 21
State
Varberg
Zip/Postal Code
43232
Country
Sweden
Inspection Range
May 30, 2016 - Jun 02, 2016
Pages
5
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