# Swiss MPC > Swiss-based regulatory consulting firm for medical devices and combination products, specializing in EU MDR/IVDR, FDA pathways, IEC 62304, UDI, and quality management systems. Swiss MPC GmbH provides senior-led regulatory consulting from Cham, Switzerland and Galway, Ireland. Founded in 2018 by Dr. Martin Walter (CEO) and Barry Keenan (CTO), the firm serves Fortune 500 medical device and combination product manufacturers as well as mid-market companies. Every engagement is led by a senior consultant who serves as your single point of contact. ## Key Facts - **Founded:** 2018 - **Headquarters:** Mugerenstrasse 72, 6330 Cham, Switzerland - **Second Office:** Galway, Ireland - **Phone:** +41 44 586 72 67 - **Email:** info@swissmpc.com - **Team:** 10+ senior regulatory professionals - **Clients include:** Zimmer Biomet, CSL Behring, Johnson & Johnson, Ovation Medical, Novartis, Limoss, Mathys Medical ## Core Expertise - EU MDR (2017/745) and IVDR (2017/746) compliance - FDA 510(k), PMA, and De Novo regulatory submissions - IEC 62304 medical device software lifecycle documentation - Medical device cybersecurity (FDA premarket guidance, IEC 81001-5-1) - UDI implementation, EUDAMED and Swissdamed registration - ISO 13485 quality management systems - ISO 14971 risk management - Clinical evaluation (CER, PMCF, PMS, PSUR) - Drug-device combination products and MDR Article 117 notified body opinions - Swiss market access and CH-REP obligations - M&A regulatory due diligence ## Services - [UDI Compliance & Implementation](https://swissmpc.com/en/services/udi): Expert UDI implementation for EU MDR & FDA compliance. - [Technical Documentation & CE Marking](https://swissmpc.com/en/services/technical-docs): Expert technical documentation and CE marking services for EU MDR/IVDR compliance. - [Clinical Affairs & Clinical Evaluation](https://swissmpc.com/en/services/clinical-affairs): Expert clinical evaluation reports (CERs), PMCF studies, literature reviews, and clinical investigation support for EU MDR compliance. - [Product Development & Engineering](https://swissmpc.com/en/services/product-dev): Expert medical device product development from feasibility through design transfer. - [Regulatory Strategy & Compliance](https://swissmpc.com/en/services/regulatory): Strategic regulatory consulting for EU MDR/IVDR transition, FDA 510(k)/PMA submissions, and multi-market registration. - [Quality Management Systems](https://swissmpc.com/en/services/qms): ISO 13485:2016 QMS design, implementation, and certification support. - [M&A Regulatory Due Diligence](https://swissmpc.com/en/services/manda): Expert regulatory due diligence for medical device M&A transactions. - [Medical Device Registration for Asia & Middle East](https://swissmpc.com/en/services/asia-me): Navigate medical device registration in China (NMPA), Japan (PMDA), India (CDSCO), South Korea (MFDS), Saudi Arabia (SFDA), and UAE (MOHAP) with expert regulatory guidance. - [Software Documentation & Cybersecurity](https://swissmpc.com/en/services/software): Expert IEC 62304 software lifecycle documentation and cybersecurity compliance for medical devices. - [Pharmaceutical Combination Products](https://swissmpc.com/en/services/pharma-combo): Expert regulatory consulting for drug-device combination products under EU MDR Article 117 and FDA 21 CFR Part 4. - [Packaging & Labeling](https://swissmpc.com/en/services/packaging): Expert medical device packaging and labeling services for EU MDR, FDA, and ISO 11607 compliance. ## Key Differentiators 1. **Swiss Senior Oversight:** Every project is supervised by senior consultants based in Switzerland 2. **3-Day Onboarding:** Consultants integrate with client teams within 3 business days 3. **Single Point of Contact:** One dedicated consultant manages each project from start to finish 4. **Competitive Packages:** Senior-level expertise at competitive rates without large-firm overhead ## Leadership - **Dr. Martin Walter, CEO & Managing Partner** — PhD in Biomedical Engineering (University of Oslo), Mechanical Engineering (TU München). Career spanning Zimmer Biomet, BIOTRONIK, Johnson & Johnson. Specializes in risk management, product development, and EU MDR strategy. - **Barry Keenan, CTO & Managing Partner** — 15+ years in medical devices at Zimmer Biomet, DePuy Synthes, Novartis, CSL Behring. Oversees all technical projects and delivery excellence. ## Pages - [Homepage](https://swissmpc.com/en) - [About Us](https://swissmpc.com/en/about) - [Services Overview](https://swissmpc.com/en/services) - [Blog](https://swissmpc.com/en/blog) - [Case Studies](https://swissmpc.com/en/case-studies) - [Glossary — Regulatory Terms](https://swissmpc.com/en/glossary) - [Regulatory Research Tool](https://swissmpc.com/en/research): AI-powered search across 750+ EU MDR, FDA, and ISO/IEC regulatory documents - [Contact](https://swissmpc.com/en/contact) - [Privacy Policy](https://swissmpc.com/en/privacy) - [Terms of Use](https://swissmpc.com/en/terms) - [Imprint](https://swissmpc.com/en/imprint) ## Blog Articles - [Design History File Remediation: A Practical Guide for Medical Device Manufacturers](https://swissmpc.com/en/blog/design-history-file-remediation-guide) - [ISO 13485 QMS Implementation Guide: Building a Compliant Quality Management System for Medical Devices](https://swissmpc.com/en/blog/iso-13485-qms-implementation-guide) - [Medical Device Cybersecurity Compliance: From Threat Modeling to Market Access](https://swissmpc.com/en/blog/medical-device-cybersecurity-compliance) - [EUDAMED Registration Guide 2026: Complete Walkthrough for Medical Device Manufacturers](https://swissmpc.com/en/blog/eudamed-registration-guide) - [EU MDR Transition Deadlines 2026-2028: Critical Dates Every Manufacturer Must Know](https://swissmpc.com/en/blog/eu-mdr-transition-deadlines) - [Post-Market Surveillance Under EU MDR: A Complete Guide to PMS, PMCF, and PSUR](https://swissmpc.com/en/blog/post-market-surveillance-guide) - [Swiss UDI Mandate and Swissdamed: What Manufacturers Need to Know](https://swissmpc.com/en/blog/swiss-udi-swissdamed-guide) - [How to Write a Clinical Evaluation Report (CER) Under EU MDR: A Practical Guide](https://swissmpc.com/en/blog/clinical-evaluation-report-guide) - [CE Marking for Medical Devices: The Complete EU MDR Guide (2026)](https://swissmpc.com/en/blog/ce-marking-medical-devices-guide) - [EU MDR Implementation: What Manufacturers Need to Know in 2026](https://swissmpc.com/en/blog/eu-mdr-2026-update) - [FDA 510(k) vs EU MDR CE Marking: A Comparative Guide](https://swissmpc.com/en/blog/fda-vs-eu-mdr) - [Getting Started with IEC 62304: A Practical Guide for Software Teams](https://swissmpc.com/en/blog/iec-62304-guide) ## Case Studies - [MDR Transition for Class III Implant Manufacturer](https://swissmpc.com/en/case-studies/mdr-transition) - [Enterprise UDI Implementation Across 500+ Devices](https://swissmpc.com/en/case-studies/udi-implementation) - [IEC 62304 Compliance for AI-Powered Diagnostic Software](https://swissmpc.com/en/case-studies/software-compliance) - [EU MDR Compliance for Drug-Eluting Combination Device](https://swissmpc.com/en/case-studies/combination-products) ## Languages The site is served in English, German and French under /en, /de and /fr. Long-form service content exists in all three; blog articles exist in English and German, and case studies in English only. Untranslated URLs are marked noindex rather than serving duplicate English content under a translated URL. ## Notes - All content is informational and does not constitute regulatory or legal advice. - The regulatory research tool and chat assistant are AI systems. Their answers are research aids, not regulatory advice, and are not a substitute for assessment by a qualified regulatory professional.