News

New MEDDEV 2.5/10 EAR

6-Feb-2012 New MEDDEV guidance on European Authorized Representatives
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Season greetings

20-Dec-2011 - We wish you a Merry Christmas and a Happy New Year in good health.
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Successful surveillance audit

26-Oct-2011 - We congratulate one of our clients with a successful ISO13485 surveillance audit today. No nonconformities were observed.
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Training course: Vigilance


Description: This course will learn you the requirements of a Medical Device Vigilance System.
Objectives: At the end of the course you will understand the structure and headlines of the requirements of a vigilance system.
Who should attend: The course is intended for employees who are involved in implementing a vigilance system in their organization.
Subjects: Subjects that are discussed during the course, are:
  • what learns MEDDEV 2.12-1 about vigilance;
  • definitions;
  • reporting requirements;
  • roles of national competent authorities;
  • roles of Notified Bodies;
Duration:
0,5 day
Location: Apeldoorn area, The Netherlands
Number of attendees: minimum 6 and maximum 12
MDD basics
+31 642 31 95 05

Agenda

The following trainings are scheduled:

  Nov ’11 Dec ’11
ISO9001:2008

ISO 9001 basics
Internal audits ISO 9001
2
ISO13485:2003


ISO 13485 basics
17
Internal audits ISO 13485

ISO 13485 for suppliers


Medical Device Directives


MDD basics

Vigilance