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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint745,194 companies indexed · Last updated: today
DirectoryBusiness & Technical ServicesManagement ConsultingChamSwiss MPC GmbH
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Swiss MPC GmbH

Summary

About the company

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.

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Regulatory Strategy & Compliance
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.
Packaging & Labeling
Label content development, UDI carrier placement, multi-language IFUs, sterile barrier validation, artwork management, and FDA/EU MDR labeling compliance.
Product Development & Engineering
Feasibility studies, design input definition, risk management integration, verification and validation planning, usability engineering, and design transfer support.
Software Documentation & Cybersecurity
IEC 62304 lifecycle documentation, SOUP management, SBOMs, cybersecurity risk management, software verification and validation, and secure development support.
Pharmaceutical Combination Products
Primary mode of action assessment, device and drug regulatory pathway mapping, NBOp support, integrated submission strategy, and lifecycle management.
Medical Device Registration for Asia & Middle East
Regulatory strategy, classification mapping, dossier preparation, local representative coordination, submission management, and post-registration compliance for Asian and Middle Eastern markets.
M&A Regulatory Due Diligence
Regulatory due diligence for acquisitions, including technical documentation review, QMS maturity assessment, clinical evidence checks, and remediation cost modeling.
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Location

Mugerenstrasse 72
6330 Cham

At a glance

Legal form
Limited Liability Company
UID
CHE-410.062.163
Founded
2018 · 8 years
Last commercial register change
November 22, 2022
Employees
11 to 20

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