EU representation for medical devices

EUSWISSMED

In the heart of medicine
Meet us at MEDICA
EUSWISSMED

Your MDR, IVDR & FDA regulatory compass
EUSWISSMED

Your Experts for EUDAMED
UDI, Registration, Admission
Automotive to Medical

Your transformation partner

Medical devices - IVDR – Pharmacovigilance solved by Experts

Our services for medium-sized medical technology, diagnostics and pharmaceutical companies

01

Implementation of the EU Medical Device Regulation (MDR)

We prepare all the necessary technical documents for a successful MDR and ISO13485 certification

02

M&A and Strategic Partnerships

Efficient organizational processes, Change Management, Financing Clinical Studies, Technical Due Diligence

03

Transformation Automotive to Medical

We help automotive suppliers to become successful in the medtech market

04

FDA for medical devices and pharma/biotech including clinical trials

We prepare 510k documents and Drug Master Files for FDA admission as well as clinical studies

05

Market Surveillance and Periodic Safety Update reports for medical devices, IVDR and medicinal products

Market surveillance and contact point for product and adverse event inquiries

06

EUDAMED registration and UDI upload for medical devices

We register your company with EUDAMED and arrange the UDI upload according to MDR Article 27 and Annex VI03EU

07

Authorized Representative and UK Responsible Person

We take over the task of the authorized person in the EU and in the UK including the preparation of all required documents

08

QPPV, Medical Advisor and PHARMACOVIGILANCE

QPPV function, MedDRA reporting of ADRs, preparation of Period Safety Update Reports (PSUR): we help!

09

EUSWISSMED is MedDRA registered

EUSWISSMED uses standardised international medical terminology for regulatory communication and evaluation of medicinal products data

Our experts

Many years of international healthcare experience

Dr. Oliver A. Kohr

Managing Director, MEDICAL TECHNOLOGY QA, RA

Schaerer Medical,
TEM Innovations

Dr. Ulrich Wandel

M&A and Strategic Partnerships

Fresenius AG, Hoechst-Aventis,
Shop Apotheke Europe

Dr. Gerhard Bauer-Lewerenz

Audits & GMP

Prof. Dr. Jörg Vienken & PV Team

QPPV

Pharmacovigilance,
Clinical Evaluation,
FDA submission

Thomas Kuck

International Contract Management

Outsourcing Specification Books
Project Contract review
International Legal Advisor