Learn how to safely pass the medical device approval process

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Software: V-Model
Prof. Dr. Christian Johner
Quality Managers, Developers, Regulatory Affairs Managers, Project Managers
Nicht verfügbar
veröffentlicht am 10.03.16
In this video training you will get to know the list of documents you have to write and compile in due course of the software life-cycle, in particular during the development process. You will learn to distinguish the different aspects the different documents have to address; for example to differentiate between user and system requirements. This is a precondition for precise and slim documents, for assigning documents to different roles, and to trace throughout the development process in a legally compliant manner.
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A safe bet - not just in audits

The E-Learning Library will help you 

  • minimize embarrassing difficulties in the audit,
  • avoid wasting time and money on rectification (a re-audit will cost about 1,000 EUR, in addition to internal resources)
  • accelerate the process to the market for your product because you will avoid unnecessary project delays, e.g due to unnecessary rectification or elaborative (retrospective) development of your technical documentation. You would be surprised to know how much a project delay would cost you, try to divide your product revenue in a year into twelve, then you can see how much it already affects your monthly cost.
  • avoid expensive consultants and save your budget up to five-figures sum.

Your investment

Compared to how much all of these will cost you, auditgarant is an absolute bargain: just 990 EUR per year. We are convinced that it is almost impossible that this investment will not benefit you straight away. Convince yourself and order now!

What our customers say

PicclientAt one point, the offers are the most comprehensive informations for this topic-
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Klaus Müller, CEO xmachina &GmbH

Picclient"I'm really surprised how you succeed to express your motivation and passion, and the fact that you did this with the not-so-easy topics. It was fun to watch the web training and answer the mindmailer. Thank you very much for putting your heart into this and so generously pass this knowledge. This way, a complex and really dry topic becomes a highly interesting topic that you can’t get enough of. Really great! "

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