SERVICES

 

Design, production and registration of medical devices and cosmetic products of herbal origin;

  • Preparation of technical documentation for CE marking of medical devices according to Council Directive 93/42/EEC, of 14 June 1993 concerning Medical Devices amended by Directive 2007/47/EEC;
  • Preparation of technical documentation for CE marking of medical devices according to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5¬†April 2017 on medical devices
  • Preparing documentation (clinical study protocol, informed consent form, patients informations, investigators brochures) for obtaining approval of the clinical investigation by ethical comity;
  • Conducting study design for preclinical and clinical trials and evaluating obtained data by various statistical methods;
  • Writing clinical study reports (CSR) for medicinal products and medical devices;
  • Writing clinical evaluation reports (CER) in accordance with MEDDEV 2.7/1 rev. 4 for medical devices both based on literature search and clinical investigation results.
  • Writing Post Market Clinical Follow -Up Report in accordance with MEDDEV V2.12-2,Rev.2
  • Safety assessment of the cosmetic products;
  • Preparation of product information (PIF) file for finished cosmetic products;
  • Adapting formulations for cosmetic products in accordance with Regulation (EC) No. 1223/2009 OF THE EUROPEAN PARLIAMENT AND THE COUNCIL of 30 November 2009 on cosmetic products;
  • Notification of finished cosmetic products on CPNP portal;
  • “Responsible person” services for cosmetic products;
  • Statistical analysis of data from the various scientific fields for the purpose of Ph.D thesis, scientific papers publishing and clinical studies.