Clinical evaluation (MEDDEV 2.7/1 Rev4)
The clinical evaluation report is a key document throughout the lifetime of a medical device and provides a comprehensive and critical assessment of the safety and performance related to benefit/risk ratio associated with the intended use of the device.
Based on the strategy described in the clinical evaluation plan, developed for each medical device or a group of medical devices, a scientific literature search followed by a systematic gating process needs to be performed and scientifically linked to the clinical safety and performance data reported for the device in question.
In parallel events reported to authorities (e.g., FDA, BfArM, etc.) must be reviewed and assessed with respect to the own product. Also, documents e.g., such as instructions for use, pre-clinical test reports, and risk management documents will be reviewed and referenced in the clinical evaluation report to meet the requirements according to MEDDEV 2.7/1 Rev 4.
The clinical and regulatory team at Optana is competent in writing clinical evaluation reports according to the MEDDEV 2.7/1 Rev4, also with addressing the new requirements according to MDR. We provide support for the entire process of the clinical evaluation, starting with the development of a well-defined strategy at the beginning of the process to reach compliance with the applicable regulations.
For our customers we create the clinical evaluation plan (CEP), continuing with the literature and event database search, followed by the review of these results, the clinical and non-clinical data of the product itself available and resulting in writing the clinical evaluation report (CER) with all information linked to each other and a conclusion stated.
Clinical trial management (ISO 14155:2020, MDR, etc.)
Optana has long lasting experience in the field of clinical trial management for medical devices since 2010 and provides services throughout the entire study. We develop all documents required to be compliant with ISO 14155.2020 (e.g., clinical trial protocol and synopsis, patient information and patient consent, monitoring plan, study specific required forms/templates/logs, etc.) and are able to lead the submission and the correspondence to authorities and ethics committees, as well as to select investigators, and manage the sites throughout the entire clinical trial.
Planning, execution and monitoring of clinical studies have to follow normative guidelines and require the consideration of ethical aspects. The performance will be controlled at the interplay of the sponsor and the clinical centers (investigator) under permanent monitoring and documentation.OPTANA has experience in the planning, application at the authorities and monitoring of clinical studies intended to generate clinical data for approval or clinical marketing purposes.
Feel free to reach out to us to discuss if our experience can be of added value for your projects and products. We are looking forward to it.