Bioptron AG - Nov. 2, 2017
Issue Date
Nov 02, 2017
Region
HQ
Category
Device
$117.00
Contact Name
Milisav Jankovic
Contact Title
Chief Business Development Manager
Address 1
Gewerberpark Rohrbuel
Address 2
Sihleggstrasse 23
City
Wollerau
Zip/Postal Code
CH-8832
Country
Switzerland
Inspection Range
Oct 30, 2017 - Nov 02, 2017
Pages
8
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