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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Downloads

Click here for the text of the MDD 93/42/EG 

Click here for the text of the IVD 98/79/EG 

Click here for the text of the AIMD 90/385/EG

Click here for an overview of notified bodies (for CE medical device directive)

Click here for an overview of harmonized standards

Click here for MEDDEV documents

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