Clinical Evaluation
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.
![Medical Device Clinical-Evaluation-Image](https://www.gpb.co.uk/wp-content/uploads/2019/06/Clinical-Evaluation-Image.jpg)
Applying MEDDEVÂ 2.7/1 revision 4 as a base we provide the necessary expertise to address the requirements of the MDRÂ / 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.
![03 – Clinical Evaluation-01 Clinical Evaluation](https://www.gpb.co.uk/wp-content/uploads/2018/02/03-Clinical-Evaluation-01.png)
Experience
We have successfully prepared Clinical Investigation Plans, Applications and completed Investigator Brochures for investigations in countries such as:
- Brazil
- France
- Germany
- Mexico
- Netherlands
- Russia
- Spain
- Sweden
- Switzerland
- UK
- 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