Ente Certificazione Macchine
Graziella Parrotta is a Technical Expert and Lead Auditor for CE and ISO 13485 at Ente Certificazione Macchine srl, specializing in both active and non-active medical devices, sterilization processes, packaging, and cleanroom standards since September 2022. Previously, while serving as a Risk Management Analyst at B. Braun Group, Graziella conducted risk assessments for disposable medical devices, adhering to ISO standards. At Amaris Consulting, contributions included developing sterility technologies and pharmaceutical support for manufacturing processes. Graziella's academic background includes a Doctoral candidacy at the University of Southern Denmark focused on peptide synthesis and characterization, as well as research internships in peptide synthesis and doping detection methods. Graziella holds a Master’s degree in Chemical and Pharmaceutical Technologies from Sapienza Università di Roma and is a licensed pharmacist.
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.