Phase 3: Clarifying Certification Questions Early

Those who have been involved with the certification process know how quickly you can get caught up in all of the red tape of regulations. OHST performs the complete conformity assessment process as is governed in the currently valid version of the European directive 93/42 EEC.

Even partially simultaneously with phase 2, during prototype creation, our development department checks the initial premises for the certification. This covers the risk analysis and the tests on technical and clinical security, there are also questions on bio-compatibility and the effectiveness of the product to be developed.

All relevant documents from this certification phase for the first part of the product files are compiled.

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