Design and development of your devices (medical devices, machines), definition of the Verification and Validation plan, project management, multidisciplinary approach combining in 1 team the industrial design, marketing and engineering aspects, processes validation (sterilization, packaging…), suppliers and subcontractors qualification, product risk management
Medical and in vitro diagnostic devices classification, regulatory compliance (Europe, Canada, USA), clinical evaluation, clinical plan development, identification of notified bodies, preparation and submission of technical files for the CE marking, regulatory watch, Post-Marketing Surveillance
As requested by the European Regulation on Medical Devices, EngiMed may acts as the Person Responsible for Regulatory Compliance.
Setting-up ISO13485 quality management system in compliance with MDSAP and European Regulatory Requirements, internal audits and audits of subcontractors, training of the staff, system risk analysis.
For SME companies, EngiMed may act as internal auditor for your Quality Management System in order to guarantee the right level of independence.
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