Founded to bring regulatory clarity to Medical Device manufacturers
An internationally operating regulatory affairs service provider headquartered in Zug, Switzerland, with offices in Hardt, Germany and London, United Kingdom.
ABOUT EUMEDIQ
Helping medical device manufacturers turn complex regulation into practical compliance
EUMEDIQ was established in Frankfurt in May 2020, when MDR and IVDR were creating new levels of regulatory complexity and uncertainty across the MedTech industry. Our founding purpose was to help medical device manufacturers bridge the gap between highly complex regulatory requirements and their simplest possible implementation in practice.
Our team of highly qualified experts supports manufacturers across authorised representation in the EU, UK, and Switzerland, regulatory and quality management consulting, auditing, interim management, and import services for foreign manufacturers in Switzerland. We maintain our own management system aligned with ISO 13485:2016 and ISO 27001, reflecting our commitment to operating at the same standard we set for our clients.
2020
Founding of EUMEDIQ GmbH
Incorporation of EUMEDIQ GmbH in Germany, establishing the foundation of the company.
2020
Founding of EUMEDIQ AG
Half a year later, EUMEDIQ AG is founded in Switzerland, extending the company's presence into the Swiss market. Later becoming the Head Office.
2021
ISO 13485 Implementation
Implementation of ISO 13485 standards to formalise quality management across the organisation.
2022
ISO 27001 Implementation
Implementation of ISO 27001 standards to formalise information security across the organisation.
2023
Launch of the EUMEDIQ Vault
Launch of the EUMEDIQ Vault, the secure document exchange and storage platform for customers.
2024
CSV launched as a service
Launch of Computerised System Validation (CSV) as a dedicated service offering.
2024
Expansion to the United Kingdom
Establishment of EUMEDIQ Ltd. in the United Kingdom, one service provider, three markets.
2025
Regulatory World Map collaboration with S-GE
Launch of the Regulatory World Map in collaboration with Switzerland Global Enterprise (S-GE).
2025
Launch of AIMEDIQ
Launch of AIMEDIQ, the AI-powered regulatory intelligence platform.
2026
10,000+ UDI-DI as Authorised Representative
Milestone of surpassing 10,000 UDI-DI represented under EUMEDIQ's Authorised Representative service.
OUR HISTORY
DEVICE PORTFOLIO IN NUMBERS
Regulatory clarity at scale, delivered across global markets
The figures below reflect the scale of EUMEDIQ's regulatory and representative activities on behalf of medical device manufacturers, providing a transparent overview of the breadth of our work and the compliance position we maintain across our active portfolio.
Each statistic represents a regulatory obligation managed to the same standard of accuracy and professional accountability that governs every aspect of EUMEDIQ's work as a service provider for the medical device industry.
1,130
Active in vitro diagnostics (IVD) across the EU, UK, and Swiss regulatory databases
8,871
Active medical devices (MD) across the EU, UK, and Swiss regulatory databases
10,001
Total active products across the EU, UK, and Swiss regulatory databases
23%
IVDR Transition Completed Share of in vitro diagnostics transitioned under IVDR 2017/746
83%
MDR Transition Completed Share of medical devices transitioned under MDR 2017/745
730+
Basic UDI-DIs assigned across our active portfolio under MDR and IVDR
MEET THE TEAM
Deep industry experience, digital capability, and a tailored approach to every engagement
Every member of the EUMEDIQ team brings more than ten years of hands-on experience across the medical device, healthcare, and clinical environments.
Natalie Rosenbach
Managing Director EUMEDIQ GmbH
Managing Director of EUMEDIQ GmbH. +10 years of experience in health care environments and clinical research environments as a nurse, quality manager and clinical research associate. Natalie is responsible for our site in Frankfurt, Germany.
Lisa Kamber
Senior Consultant
Senior Consultant. +10 years of experience in medical device & clinical environments with solid expertise in the qualification & validation of the manufacturing processes of implants and consumables. She also has a profound understanding of clinical laboratory processes and extensive experience in Kanban methodology. Lisa acts as a TÜV Süd certified Safety Expert non-active medical devices and has a Master of Science in Biomedical Engineering from the Swiss Federal Institute of Technology, Zurich (ETH).
Mike Seidenberg
CEO & Founder
Founder and CEO of EUMEDIQ. Mike brings over 10 years of leadership experience in quality management and regulatory affairs at globally recognised medical device companies, including extensive work with Notified Bodies and National Competent Authorities. He is an IRCA certified Lead Auditor (BSI) for ISO 13485 and ISO 27001, a certified Manager of Regulatory Affairs (TÜV Süd), and a Safety Expert for active medical devices.
Anina Park
Accounting, Administration & Import
Anina ensures accuracy across all back-office operations: payments, billing, VAT, expenses, and controlling, as well as import transactions and customs matters. She brings experience from store management in retail and food service, holds a federal diploma in restaurant services, and has previously worked as an accountant in a trustee office.
Ramin Amiri
Regulatory Affairs Manager
Regulatory Affairs Manager with over 10 years of experience in quality management and regulatory affairs at medical device manufacturers. Ramin has led successful worldwide submissions across Europe, Japan, Australia, and Canada, and an MDSAP certification. He currently acts as person responsible for regulatory compliance for a Swiss manufacturer, and holds an MSc in Quality Management.
Gabi Latz
Quality Support
Gabi focuses on the review of technical documentation at EUMEDIQ, ensuring every document meets internal quality procedures and external regulatory expectations. Before joining EUMEDIQ, she spent eight years at Medela AG, where she developed deep expertise in document and change management within a globally operating medical device manufacturer.
Unja
Good Clinical Pawctices (GCP) Specialist
As Good Clinical Pawctices (GCP) Specialist, Unja upholds the highest standards of "Good Girl" conduct in the office. With an exceptional nose for compliance and a heart for belly rubs, she oversees treat distribution, cuddle breaks, and belly rub protocols. No document leaves her desk without a final paw approval.