EN-ISO 13485:2016
CLINICAL TRIAL
UDI
EU MDR EC-REP Services
International Regulatory consulting
International Quality consulting
With MPS your products and projects are safe
With our wide spectrum of services we can fully support you. Please contact us for more information
UK Medical Device Responsible Person
MPS can register medical devices with the UK Competent Authority (MHRA), maintain your registrations and act as your UK Responsible Person.
EUMedical Device Responsible Person
MPS can register medical devices with the EU Competent Authority (MDR), maintain your registrations and act as your EU Responsible Person.
International Regulatory and Quality consulting
We can help you develop a regulatory strategy and can develop you a tailor made Quality Management System to fit your needs.
EU MDR EC-REP Services
Via MPS (GMBH) we can help you comply with the EU Medical Device Regulations and the need for an EC-REP.
Shipping
We support you in shipping your products in Europe
Storage
We offer you suitable storage facilities
ISO - 13485 consulting
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ISO -31000
RISK-MANAGEMT
ISO- 17025
Labor Management
ISO - 9001
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Our Mission
Our mission are safe products and high availability in the market. For this reason we cooperate with international customers and companies and support the best medical products worldwide on the European market. The focus is always on the safety of the patients. An international team of professionals supports you in the approval and monitoring of your products. Subsidiaries outside the EU provide support on international issues.
Current employees
Tanja Frömel
Regulatory Assistant
Reuben Lawson
US engagements.
Gerhard Frömel
C E O
Marcel Schneider
EU Regulatory Assistant
Ben Wensley-Stock
LEAD MPS UK
Michael Kornmann
ISO-13485 Lead Auditor