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MEDICA
November 18-21, 2019
Dusseldorf, Germany
Booth #10B05





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MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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(+49)-511-6262 8630
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(+49) -511-6262 8633

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Research of Standards


The application of standards as evidence of compliance with the essential requirements is basically optional. Nevertheless, in terms of liability, applying them can be decisive when documenting that the product complies with the generally acknowledged  state of the art and, in this regard, provides the company with a certain legal security.

The standardization in medical engineering is in constant progress. It is not always easy to keep track of things and provide the resources for monitoring these activities.

What is the difference between  standards in general and harmonized standards? Which is the current revision and which standard falls in my field of activity at all? Are there specific standards for my medical device or in-vitro-diagnostic device, with additional requirements for documenting the regulatory conformity in order to fulfill the essential requirements?

The question that arises initially concerns the applicable standards for the development of new products. However, even in later phases of the life cycle, the manufacturer is obliged to assess changes in the requirements or to adapt the products. This can be caused, for example, by revisions or amendments of harmonized standards and by new standards. Last, but not least, legal changes or the globalization and regulatory consensus building also play a crucial role in the standards scenery.

Use the experience of the MDSS Consulting GmbH. We will guide you safely through the jungle of standards.


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