Service Description

Navigate the complex regulatory landscape with confidence. We analyze your regulatory needs and define strategic action plans to ensure your medical device meets all EU MDR and compliance requirements. - Medical device assessment and classification (EU MDR) - Market and regulatory pathway definition - Gap analysis and regulatory compliance - Documentation, labeling, and quality management optimization (ISO 13485 conformity assessment) - Align regulation with product development (Design and Risk Management Inputs, V&V, Clinical Evidence) - Drafting/supporting the development of Technical Files and related system documentation - Definition and implementation of the post-market surveillance (PMS) process (PMS plan and report, PSUR, periodic safety summary, and trend analysis). - Drafting/supporting the development of the CEP (Clinical Evaluation Plan), CER (Clinical Evaluation Report), and PMCF (Post-Marketing Clinical Follow-up) in accordance with MDR and IVDR. - Definition and implementation of the UDI system