• support in the scope of applications/notifications to state offices (Chief Sanitary Inspector, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products)
• development of graphic designs and packaging/label content in accordance with current legal requirements
• development of product quality specifications and other product quality documentation necessary for registration or notification purposes
• preparation of Technical Documentation for medical devices of Class I or II, including technical data on devices and processes, clinical assessment reports based on literature analysis, biocompatibility reports, Safety Data Sheets,
risk assessment, compliance declaration
• cooperation with external laboratories in the field of carrying out cytotoxicity, irritation and sensitisation tests, microbiological purity tests, preservative effectiveness tests, nutritional value tests and many others