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Home  > Experts  > Rafael J. de la Roza

Rafael J. de la Roza
Expertprofile

 
Rafael J. de la Roza
Germany
63743 Aschaffenburg

+49-6021-4380502
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Rafael J. de la Roza
Consultant / Author / Journalist
1954
German
English
Rafael J. de la Roza
-
D-63743 Aschaffenburg
+49-6021-4380502
no details
Send inquiry to Rafael J. de la Roza
See the statistics of Rafael J. de la Roza 
in the last 30 days
(valid since 17.10.2008):
Total 83
Germany 46
USA 12
Austria 6
India 6
Switzerland 5
Canada 5
United Kingdom 3
28-Feb-2008
Expertprofile
16
1

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Expertise of  Rafael J. de la Roza

Personal profile - Rafael J. de la Roza

As a previous executive manager and auditor in internationally recognised certification societies for quality management systems (QM-systems) and „notified bodies“ for medical devices (Det Norske Veritas, TÜV Nord) I offer you any required support in the area of the quality management and CE-marking of medical devices, such as

  • consultancy and assistance in the development of QM-systems according to ISO 9001 / EN 13485 / EU Medical Device Directive
  • preparation of the QM-manual and further related procedures
  • advisory in the preparation of the technical file and the Risk Management (EN 14971) for your medical devices
  • internal audits and preparation for the certification audit
  • training with respect to the implementation of the Medical Device Directive
  • trainings for the Safety Responsibles and Medical Device Advisors according to the German Medical Device Act

Your company works in the international environment? No problem – fluency in English, German and Spanish!

Moreover, I work as a specialised journalist (freelancer) with a focus on medical device law and occupational safety and health.

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