Clinicology has a team of Clinical Project Managers and Clinical Research Associates that have extensive experience in the management of Medical Device trials.
The team has have an in-depth knowledge of ISO14155:2020, MDR and the changes from MDD and have the expertise to understand the nuances between running CTIMP and Medical device trials.
Our portfolio of Medical device trials includes Class 2a, 2b and Class 3 devices in both the pre-market space and post-market Clinical Follow up. We can also provide support for combination products (device and IMP).
- Post Market Surveillance planning
- Support for regulatory applications
- Site identification and selection
- Risk-based monitoring
- Adverse event and device deficiency processing