The core activity of Swiss MPC is to provide services in the field of regulatory compliance for medical devices and pharmaceuticals, including project management, risk management, product development, technical documentation, clinical affairs and quality management systems. The company supports customers in obtaining the CE marking and offers comprehensive solutions for compliance with EU regulations, in particular the EU Medical Device Regulation.
Regulatory roadmaps, pathway identification, MDR/IVDR transition, and notified body interaction for medical devices and combination products across EU, FDA, and other markets.
Technical Documentation & CE Marking
Technical files, Design History Files, GSPR mapping, notified body submissions, and CE marking support for EU MDR, IVDR, and FDA pathways.
Quality Management Systems
ISO 13485:2016 QMS design and implementation, FDA QSR alignment, gap analysis, SOPs, CAPA, internal audits, and audit readiness.
Clinical Affairs & Clinical Evaluation
Clinical evaluation reports, systematic literature reviews, equivalence assessments, PMCF planning, clinical investigation support, and ongoing clinical data management.
UDI Compliance & Implementation
UDI-DI assignment, EUDAMED and GUDID registration, label integration, direct marking, and ERP/PLM data integration for medical devices.
Knowledge
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