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Medical devices - IVDR – Pharmacovigilance solved by Experts
Our services for medium-sized medical technology, diagnostics and pharmaceutical companies01
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!
A reliable partner
in a demanding market.
Our experts
Many years of international healthcare experience
Dr. Oliver A. Kohr
Managing Director, MEDICAL TECHNOLOGY QA, RASchaerer Medical,
TEM Innovations
Dr. Ulrich Wandel
M&A and Strategic PartnershipsFresenius AG, Hoechst-Aventis,
Shop Apotheke Europe
Dr. Gerhard Bauer-Lewerenz
Audits & GMP
Prof. Dr. Jörg Vienken & PV Team
QPPVPharmacovigilance,
Clinical Evaluation,
FDA submission