Gabriele Catignoli

- Review of technical documentation and STED documents - Performing gap assessments between Gambro and Baxter technical documentations, with the goal of compliance to Baxter - Providing inputs for required changes to the Senior Management - Development of the CE database for all Gambro medical devices, according to Baxter’s requirements

Performing internal audits in biomedical companies (ISO 9001, ISO 13485, MDD 93/42/EEC and GMP) - Orthopaedics prosthesis, electromedical devices and active pharmaceutical ingredients Suplier Quality Auditor Supporting CAPA management SOP development Validation of sampling plans Development of risk analysis (FMEA, ISO 14971)

Engineering for cell, tissues, biomaterials and biotechnologies

Fundamentals of electronic, mechanic and biology. Thesis: Production of nano and micro structured substrates with electrospinning. Mark 91/110