Your Products in compliance around the world
Your Products in compliance around the world

                                               AUTHORIZED

        European Representative

Bionok as your Authorized Reprensentative for medical devices acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the Medical Device Directive MDD 93/42/EEC or soon in the new Regulation EEC proposed as well as additional services regarding the marketing of your medical devices within the European Community.

 

 

  • Fast product registrations to the EU Competent Authorities.
  • Guidance in the preparation of Declarations of Conformity.
  • Guidance in the labeling and language requirements in Europe.
  • Incident reporting to the Competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state.
  • Notification services for clinical investigations.
  • Application of Free Sales Certificates or Certificates of Marketability.
  • Provision of Certificates of product registration.

BIONOK HEALTHCARE     28042 Madrid

           English/Spanish

Phone:+34.911.371.170

info@bionok.eu  

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© BIONOK HEALTHCARE, S.L. - info@bionok.eu - 28042- Madrid-Spain Technical Office: Domenico Veneciano, 1 - 45223 Seseña.