We offer the following services

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