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IGZ verification of class I MDD IVD

31 Aug 2016 - On 5 September IGZ will issue online questioniares to manufacturers of class I medical devices and in-vitro diagnostics.
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MDR / IVDR text approved

16 Jun 2016 - Both the European Commission and ENVI have approved unanimously the text for the MDR and IVDR. The start of a new era ...
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Draft MDR / IVDR published

13 Jun 2016 - ENVI published the draft consolidated text of the MDR and IVDR yesterday ...
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Udo Consultancy was founded in 2003 by Rob Udo. Since 1991 I have experience in establishing, maintaining and improving quality management systems according to different standards, including ISO 13485, European Directive on medical devices and ISO 9001. I gained this experience in various roles holding responsibilities for quality assurance and regulatory affairs.

My vision is that a management system should have added value for your organization. Your management system should fit your organization.
Your management system should work for you and not the other way around.

Feel free to contact me for a free inquiry.

Rob Udo
Udo Consultancy

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