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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Internal Audits

An audit is usually carried out to check the status of the quality management system in relation to a  standard. We speak of an internal audit as this is done by a company on its own quality management system. This can be done both by own staff as by external experts.

If you have internal audits performed by your own staff you can use our questionnaires for ISO 9001 or ISO 13485 in the preparation and implementation of the internal audit. Our list of findings can help you to clearly formulate your findings during the audit.

You can also choose to outsource your internal audits to us. After performing the audit we will:

Please feel free to contact us to find out what we can do for you.

 

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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