CE-certification

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European Legislation regarding Medical Devices is in continuous development.

Understanding of the correct and current process of development and product life-cycle is essential to produce the correct documentation and obtain CE mark in a "time-saving" manner.

Technical File, Essential Requirements, Risk Management, Post-market Surveillance are all concepts you should perfectly know before planning the development of a new product.

Clause will help in all these:

CE marking
We support companies in the preparation of the technical dossier in accordance with standards and regulations for obtaining the CE product marking all over Europe