Certification of Medical Device

CE-certification

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

  •   Risk Management according to ISO 14971 
    We assist Medical Companies in the preparation and maintenance of the risk analysis according to ISO 14971
  •   Health Ministry Registration ITA and EU;
    Regional Market Access 
    We perform medical devices and IVD registrations in the databases of the Ministries of Health. We deal with Market Access at Italian regional level.
  •   Post market surveillance 
    We assist Medical Companies in terms of post-market surveillance: the complaints management and notification to the competent authorities.
  •   Health advertising and free sale certificate
    We offer support in the authorization request and the review of advertising material for Italian market; and assist companies in obtaining free sale certificates 
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