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: ISO 13485 for suppliers


Descriptions: This course will learn you what the ISO13485 requirements mean for you as a supplier to the medical device industry.
Objectives: At the end of the course you understand your customers specific requirements for the medical device industry.
Who should attend: The course is intended for supplier to medical device related companies to gain an undderstanding of the ISO 13485 requirements.
Subjects: Subjects that are discussed during the course, are:
  • plaats van de ISO 13485 binnen de medische industrie
  • structuur van de ISO13485 norm
  • gevolgen voor u als toeleverancier
Duationr:
0,5 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