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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Audits-introduction

An audit is usually carried out to check the status of the quality management system in relation to a  standard. In other words: does the quality management system meets the requirements of the standard and is it implemented in the daily operations.

We can offer different types of audits to you, including internal audits, supplier audits and audits on the basis of ISO 10002: 2004 (standard on complaints management ).

After performing an audit we will:

 

DEKRA Certification BV

We are working as a contractor for DEKRA Certification BV (formerly KEMA Quality BV) as Lead auditor for ISO 9001, ISO 13485 and as a Notified Body auditor for the European medical devices directive.




We are working as a contractor for SQA services Inc, USA, for the performance of supplier evaluations at European suppliers in the medical and pharmaceutical sector.


+31 642 31 95 05

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