Medical Device
Clinical Development
Medical Device
Clinical Development
Medical expertise meets
operational execution
Medical expertise meets
operational execution
Medical device clinical development has become significantly more demanding under the European Medical Device Regulation (EU MDR), requiring robust clinical evidence throughout the entire product lifecycle.
From first-in-human investigations to
post-market surveillance studies and
post-market clinical follow-up (PMCF) studies, as well as, observational and performance studies, Verum offers
customer-oriented integrated regulatory,
medical, and operational strategy.
Plan your study
before it starts
Verum delivers high-quality clinical evidence and ensure compliance with changing European regulations through smart strategic planning, streamlined study execution, and hands-on regulatory support.
Explore the
working model
Medical Device Development Areas
Clinical Investigations
(Class IIa/b and III)Software as a
Medical Device (SaMD)Post-Market Surveillance (PMS)
Post-Market Clinical
Follow-up (PMCF)Observational Studies
and RegistriesPerformance Studies
Medical device clinical development has become significantly more demanding under the European Medical Device Regulation (EU MDR), requiring robust clinical evidence throughout the entire product lifecycle.
From first-in-human investigations to post-market surveillance studies and post-market clinical follow-up (PMCF) studies, as well as, observational and performance studies, Verum offers customer-oriented integrated regulatory, medical, and operational strategy.
Plan your study
before it starts
Verum delivers high-quality clinical evidence and ensure compliance with changing European regulations through smart strategic planning, streamlined study execution, and hands-on regulatory support.
Explore the
working model
Medical Device Development Areas
Clinical Investigations (Class IIa/b and III)
Software as a Medical Device (SaMD)
Post-Market Surveillance (PMS)
Post-Market Clinical Follow-up (PMCF)
Observational Studies and Registries
Performance Studies
Why Sponsors choose
Verum in Medical Devices
Clinical Development
-
Integrated clinical development strategies aligned with EU Medical Devices Research requirements -
Experience supporting clinical investigations, PMCF, observational studies, registries
-
Regulatory and ethics expertise across multiple European countries
-
Strategic site selection and operational planning adapted to medical device studies
-
Efficient coordination of clinical, regulatory, and operational activities throughout the product lifecycle
verum.de GmbH
Kraillinger Str. 1
D-82152 Planegg
Germany
T +49 89 800 777 60
F +49 89 800 777 88
verum@verum.de
© Verum.de GmbH | 2026
