The MDR is coming – ZINDEL highlights what's important

A new EU Directive is expected to come into force this year with the "Medical Device Regulation (MDR)" which is intended to supercede the currently applicable "Medical Device Directive (MDD)". This will have far-reaching consequences. Unlike the MDD, the MDR is a regulation and, immediately after resolution, will apply in all EU countries as it no longer needs to be transposed into national law. And it will have much more stringent rules for the documentation of medical products than before: In the future, for example, these products must be comprehensible for all parties involved – authorities as well as medical specialists and patients.

Because this requires facts and orientation. Here at ZINDEL, we provide you with both and therefore cordially invite you to an exciting and highly topical seminar day on the complex subject of "Product information for medical devices".

Three expert lectures and a practical report will shed light on the new requirements against the background of current legislation. The seminar is aimed at managing directors, heads of department, editors and translators who are responsible for the development and approval of medical devices as well as for instructions for use.

The speakers and their subjects:   

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Ralf Heinsohn, Olympus Surgical Technologies Europe Olympus Winter & Ibe GmbH:

What is changed by the new MDR   
Consequences of the Medical Device Regulation for technical documentation 

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Matthias Schulz, tekom-Normendienst:

Standard requirements   
Requirements from standards on the manufacturers of medical devices   

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Christian Schmid, Söring GmbH, und Lars Schiller, ZINDEL AG:

Practical report   
Experiences with the outsourcing of editorial work and translation at Söring   

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Thomas Wedde, docConsult GmbH

Quality of translations   
What must be heeded in the selection, assessment and auditing of translators   

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The "Requirements on product information for medical devices" seminar day takes place on Tuesday, May 6, 2014, from 9:00 to around 16:30 h.   

Your investment: 390 euro + VAT.   

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We look forward to welcoming you to this extremely informative event at ZINDEL.   

The closing date for registration is April 22, 2014.   

Anmeldeformular herunterladen 

Bildernachweis: © nmann77 - Fotolia.com

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