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.