Ente Certificazione Macchine
Vanessa Biavati is an experienced professional in the field of medical device certification and quality management. Currently serving as MDR (EU) 2017/745 and MDD 93/42/CEE Technical Manager at Ente Certificazione Macchine since January 2015, Vanessa Biavati is responsible for drafting technical and management procedures necessary for achieving ministerial authorization for medical device certification. This role includes establishing qualification criteria for personnel involved in conformity assessment activities. Previously, from May 2001 to December 2014, Vanessa Biavati held the position of Quality Assurance and Regulatory Affairs Assistant and Technical Specialist at SIARE ENGINEERING INTERNATIONAL GROUP srl, focusing on updating work instructions and design specifications for various medical devices. Vanessa Biavati holds a Master's degree in Electrical and Electronics Engineering from Alma Mater Studiorum – Università di Bologna.
Ente Certificazione Macchine
ECM can boast a twenty-year experience in the certification of products, machinery and work equipment, becoming a point of reference for companies in the filed of verifications of compliance, both for the standards imposed by EU directives as well as various international standards. Through its four operational divisions - certifications, testing, inspections and training - ECM is able to offer a wide range of quality and safety related services. ECM is: - Notified Body for EU Directives and Regulations: Machinery, EMC, RED, Noise Emission, Atex, Lifts, Medical Devices, - QMS ISO 13485 Certification Body, - Accredited Testing Laboratory ISO 17025, - Inspection and Training Body.