Meeting Medical Device Regulation (EU) 2017/745 (MDR) & 746 (IVDR) and other national requirements, to provide Clinical Data that supports the medical device performance and safety claims.
Using our expertise we assist you review pre-clinical and/or bench studies, assess substantial equivalence, complete literature reviews, establish clinical protocols, clinical investigation / IDE applications, clinical investigations plans & reports in accordance with ISO 14155.
Evidencing medical device safety and clinical performance & completing Clinical Evaluation in compliance with EC, FDA and other national regulatory requirements.
Applying MEDDEV 2.7/1 revision 4 as a base we provide the necessary expertise to address the requirements of the MDR / IVDR to develop, implement and complete:
Test Protocols to establish GSPR
Clinical Investigation Protocol(s) & Plans
Clinical investigation / IDE applications
Clinical Investigation Report(s)
Clinical Evaluation Plan(s) & Report(s)
Post Market Clinical Follow Up (PMCF) and Trend Reports
We provide training in Clinical Evaluation (See Training) and the necessary support thereafter.
We have successfully prepared Clinical Investigation Plans, Applications and completed Investigator Brochures for investigations in countries such as:
- USA (IDE)
Investigational Devices have included:
- Long term implantable devices
- Single use and re-use devices
- Medical instruments & surgical devices
- Stand alone software
- Active Therapeutic Devices
- Combination Devices