Quality assurance

▪ Implementation and maintenance of Quality System compliance to European standard, i.e. ISO 13485, ISO 14155, series ISO 10993, series ISO 5840, series ISO 14644, series ISO 14155 and Meddev, process and product technical norms. 
▪ Medical devices risk management compliant to ISO 14971 for design process, final technical responses and failure investigation reports. 
▪ Writing and implementing Quality Manual, SOPs and Work Instructions related to QMS
▪ Audit.

▪ Start up the electromedical devices network in the assigned area 
▪ Sales responsibility and forecasts 
▪ Planning and managing events at medical fairs and conventions 
▪ Warranties and claim management 
▪ Technical training 
▪ Maintenance of medical devices (Directive 93/42/CEE and following modifications and revisions) 
▪ Field role (90% travelling)

▪ Production of biodegradable scaffolds for differentiation of staminal cells toward regeneration of infarcted myocardial tissue; 
▪ Synthesis techniques of biodegradable polyurethane (TIPS, salt leaching, electrospinning, rapid prototyping); 
▪ Chemical characterization techniques (infrared spectroscopy and size exclusion chromatography), thermal (DSC) and morphology (SEM); 
▪ Characterization techniques of scaffold on surface (plasma surface treatment, contact angle, fluid uptake) and in bulck with proteins and peptides.

▪ Certificate Master Quality®: Manager Consultant - Management Consultant designer, systems analyst and evaluator of Management Systems Quality, Safety, Environment and Social Responsibility;  
▪ Certificate Designer and Evaluator Quality Systems: UNI EN ISO 9001: 2015 and UNI EN ISO 9004: 2009;  
▪ Certificate Course ANGQ Auditor / Audit Group Officers of the qualified CEPAS Quality Management Systems;  
▪ Certificate Planner and Assessor Environment Systems: UNI EN ISO 14001:2015;  
▪ Certificate verification environmental legislation and waste management;  
▪ Certificate Consultant Designer of the Health and Safety Management Systems in the workplace (RSPPRLS): OHSAS 18001: 2007 / EN ISO 19011: 2012;  
▪ Course for Officers of the Prevention and Security- Form A and C (Legislative Decree no. 81/2008)  
▪ Certificate Policy Consultant Designer: Legislative Decree no. 196/2003;  
▪ Certificate Assessor System Engineer SA 8000: Ethical Quality - SA8000 standard;  
▪ Certificate Designer and evaluator in the management model Decree. N. 231/2001 and Basilea 2  

Thesis in Regenerative Medicine: "Design and development of porous matrices based on polyurethanes for         biodegradable applications in engineering of cardiac tissue". 
In collaboration with the Department of mechanical and aerospace engineering (DIMEAS), Torino, and Eltek Group S.p.A. Aosta. Supervisor: Prof. Gianluca Ciardelli, Ing. Monica Boffito PhD. 

Thesis: "Mechanical modeling of bone tissue." Supervisor Prof. Iunio Iervolino.