QMS (Quality Management System) support:
• Processes definition, evaluation, and optimization (FDA QSR, ISO 9001, ISO 13485:2016, and MDR compliant)
Product Development & Manufacturing support:
• Product design & development process/planning
• Software development process/planning (MDR, ISO 62304:2015, and FDA Regulations compliant)
• Risk Management process, planning and execution support (ISO 14971:2019 compliant)
• Product & Equipment verification and validation (R&TTE, FCC, IEC 60601-1, ed.3.2, IEC 60601-1-2, ed. 4.1 compliant)
• Design transfer (for production)
• Design reviews preparation, execution, and follow-up
• RMF (Risk Management File) compilation
• Technical documentation/dossier compilation (DHF – Design History File, DMR – Device Master Record, DHR – Device History Record)
Quality & Design Assurance support:
• Risks definition and analyses brainstorm sessions
• Internal and external (supplier) audits preparation, execution and follow-up (ISO 19011:2018)
• Management reviews process definition, preparation, execution and follow-up
• Change Control process definition, planning and execution
• CAPA (Corrective & Preventive Actions) process definition, root cause analyses, actions planning and execution
Project Management support:
• Mentoring continuous improvement and problem-solving initiatives
• Project risk management/mitigation
• Project budgets/resources planning
• Conflicts resolution