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.

News and events

Clause will participate in Arabian Health
24.01.2017
Clause will participate in Arabian Health

News
21.09.2016
CLAUSE Ltd, the leading contract research organization in Europe is pleased to announce the opening of a new branch office in Praha, Czech Republic.

Сontacts

We will be glad to cooperate

Feel free to contact us for any questions using any convinient way for you!

Tel +38 095 596 0666; +38 057 751 66 99

e-mail: office@clause-audit.com

Address: 20V, Kul'tury str., off.19

Kharkiv ,61058,Ukraine

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