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: Internal audits ISO 13485


Description: This course will learn you the basics of planning, preparing, executing and reporting of internal audits to cover the ISO 13485 requirements.
Objectives: At the end pf the course you are able to perform internal audits on an ISO 13485 quality management system to verify if it is effectively implemented and maintained.
Who should attend: The course is intended for employees which who are going to perform internal audits.
Subjects: Subjects that are discussed during the course, are.:
  • keys to improvement
  • structure of the ISO13485 standard
  • position of ISO 13485 in the medical device industry
  • audit preperation
  • objective evidence
  • audit report writing
Duration:
1 day
Location:
Apeldoorn area, The Netherlands
Number of attendees: minimum 6 and maximum 12
+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