EU representation for medical devices

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

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

03

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

04

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

05

QPPV, Medical Advisor and PHARMACOVIGILANCE

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

06

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

Our experts

Many years of international healthcare experience

Dr. Oliver A. Kohr

MEDICAL TECHNOLOGY QA, RA

Schaerer Medical,
TEM Innovations

Dr. Ulrich Wandel

Business Development

Hoechst-Aventis,
Fresenius AG

Wolfgang Werner

Quality & Regulatory Affairs

TÜV Süd,
Berlin Heart

Prof. Dr. Jörg Vienken & PV Team

QPPV

Pharmacovigilance,
Clinical Evaluation,
FDA submission