# 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 and mid-market companies with a 100% compliance success rate. 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 with 200+ years combined experience - **Clients:** Zimmer Biomet, CSL Behring, Ovation Medical, Erbe, and others ## Core Expertise - EU MDR (2017/745) and IVDR (2017/746) compliance - FDA 510(k), PMA, and De Novo regulatory submissions - IEC 62304 software lifecycle documentation - Cybersecurity compliance (IEC 62443, IEC 81001-5-1) - UDI implementation (EUDAMED, GUDID) - ISO 13485 quality management systems - Clinical Evaluation Reports (CER) and PMCF - Risk management (ISO 14971) - CE marking and technical documentation - Post-market surveillance - Drug-device combination product strategy (PMOA, NBOp, EU MDR Article 117) ## Services - [Regulatory Strategy & Compliance](https://swissmpc.com/en/services/regulatory): EU MDR/IVDR and FDA regulatory pathway planning, notified body interactions, and compliance roadmaps - [Technical Documentation & CE Marking](https://swissmpc.com/en/services/technical-docs): Technical files, Design History Files, EU MDR/IVDR submissions, and FDA 510(k)/PMA documentation - [UDI Compliance](https://swissmpc.com/en/services/udi): EUDAMED and GUDID registration, labeling integration, direct marking, and UDI-DI/UDI-PI assignment - [Clinical Affairs](https://swissmpc.com/en/services/clinical-affairs): Clinical Evaluation Reports, literature reviews, PMCF planning, and clinical investigation support - [Product Development & Engineering](https://swissmpc.com/en/services/product-dev): Feasibility studies, risk management, design validation, and market analysis - [Quality Management Systems](https://swissmpc.com/en/services/qms): ISO 13485:2016 design and implementation, FDA QSR compliance, gap analysis, SOPs, and audit readiness - [IEC 62304 Software Documentation & Cybersecurity](https://swissmpc.com/en/services/software): Software lifecycle documentation, cybersecurity compliance, SBOM management, and secure development environments - [M&A Due Diligence](https://swissmpc.com/en/services/manda): Regulatory compliance audits, documentation reviews, and risk assessment for medical device acquisitions - [MDR for Asia & Middle East](https://swissmpc.com/en/services/asia-me): NMPA, PMDA, CDSCO, MFDS, SFDA, and MOHAP regulatory transition support - [Pharmaceutical Combination Products](https://swissmpc.com/en/services/pharma-combo): Drug-device combination regulatory strategy, PMOA determination, and Notified Body Opinion support - [Packaging & Labeling](https://swissmpc.com/en/services/packaging): EU MDR/FDA labeling compliance, ISO 15223-1 symbols, sterile packaging, and multi-language IFU ## 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 - [EUDAMED Registration Guide 2026: Complete Walkthrough for 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: 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](https://swissmpc.com/en/blog/clinical-evaluation-report-guide) - [CE Marking for Medical Devices: The Complete EU MDR Guide](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)