EN-ISO 13485:2016
CLINICAL TRIAL
UDI
EU MDR EC-REP Services
International Regulatory consulting
International Quality consulting
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
EN-ISO 13485:2016
Impelemtation and optimization of QM system
supervision of internal and external audits
UDI
Support for the implementation of MDR requirements at UDI
CLINICAL TRIAL
support for the implementation of clinical trials