Table of Contents
Advertisement
9
MONITOR OF
AFTER-SALE INCIDENTS
PRO MEDICARE S.r.l.
compliance with the criteria and requirements established by the relevant National EU rules and
give adequate security of operation in the conditions required by Directive N° 93/42/EEC and
subsequent amendments and additions for after-sale monitoring.
We consider it essential to monitor via after-sale and service, the reliability of our products and
constantly search to improve the quality of our devices. The monitoring of any incident that may
have caused serious physical harm to end users, their caregivers or to a clinical professional/
authorised dealer in connection with the use of any device, we will comply with the safety
standards set by the Directive.
lt follows that, in the case of any incident.
to send to the producer a copy of the
As soon as
PRO MEDICARE
appropriate authorised professional all information, as well as an authorisation to repair the
damage device, or its complete replacement.
IN URGENT CASES IT IS DULY RECOMMENDED TO CALL THE PRODUCER
AT THE FOLLOWING NUMBER:
SENDING AS SOON AS POSSIBLE BY FAX THE
INSTRUCTION MANUAL
ensures that their medical device products are produced within strict
IT IS DULY REQUIRED
Annex 2
S.r.l., receives the above form, we will immediately report to the
+39 0831 777840
completed in all its parts.
ANNEX 2
CDULY COMPLETED.
www.versainserto.com
Page
12
Advertisement
Table of Contents
