Emanuele Buttazzoni Email and Phone Number

Limacorporate S.p.A. - Regulatory Affairs Coordinator - 05/2014 - currently engaged- Renewal of all the Limacorporate CE certificates for the Class III Medical Devices;- Strict cooperation with the notified bodies (TUV SUD, BSI and DEKRA);- Involvement in project teams for the development of new products;- Activities for the preparation of Clinical Evaluation Reports according to Meddev 2.7.1;- Registration of Limacorporate Physica knee replacement system in USA (ongoing);- Registration of Limacorporate SMR Reverse shoulder system in Japan;- Activities for new product registrations with CFDA (China);- Activities for new product registrations with MFDS (Korea);- Business trip in China and Korea for selection of local RA consulting agencies;- Cooperation with several consulting partners (i.e. Emergo, YES, NAMSA);- Regulatory Activities planning.Limacorporate S.p.A. - Regulatory Affairs Assistant - 05/2008 04/2014- Preparation and update of the technical-scientific documentation for the CE marking of medical devices (class I, IIa, IIb and III) according to EEC/93/42;- Preparation of the technical-scientific documentation for medical devices registration in non-European countries (in particular Japan, China, Korea and United States);- Insertion and update of Medical Devices in the Italian Registry of Medical Devices;- Cooperation and team-work with different functions (designers, laboratories for mechanical tests, involvement in project teams for the development of new products);- Cooperation with Limacorporate mechanical laboratory for development of test protocols.