Medical devices
Support for device studies requiring experienced monitoring, operational oversight, and country-specific coordination in Germany.
Medical device clinical trial support in Germany
Medical device projects require practical coordination across sites, documentation, timelines, and regulatory expectations. Support can include pre-market and post-market clinical activities in Germany, with direct senior involvement and clear communication throughout the project.
- Clinical investigations for medical devices
- Study start-up and site activation support
- Monitoring and site management
- Regulatory and ethics documentation support
- PMCF and post-market clinical activities
- Selected real-world data or real-world evidence-related projects where applicable
Project types
- Standalone medical device clinical investigations
- Drug-device combination products
- In vitro diagnostic and companion diagnostic studies
- Post-market studies and PMCF-related activities
- Projects requiring coordination between operational and regulatory workstreams
Operational support
- Feasibility and site identification
- Site qualification, initiation, monitoring, and close-out
- Study documentation review and follow-up
- Communication with sites, sponsors, CROs, and stakeholders
- Tracking of open items, risks, and timelines
Regulatory and post-market perspective
Medical device support may involve ethics coordination, local submission requirements, documentation review, PMCF-related activities, and broader post-market evidence generation. Depending on the project, this can include practical support for real-world data or real-world evidence-related work.
IVD and companion diagnostics
Support for selected diagnostic-related studies where documentation quality, site coordination, and practical execution are critical.
Combination products
Cross-functional perspective for projects that sit between pharmaceutical and medical device workstreams.
Need support for a medical device study in Germany?
Please send your device type, study phase, timeline, and support needs. I respond personally.