Conducting a clinical evaluation is binding for all distributers of medical devices.
This task requires special competences, regarding the approval of medical devices, quality management, medical risk analysis and a profound knowledge about technological and medical correlations.
This combination and much more is offered you by senetics. We are happy to support you with the following services:
- Preparation of new or updated clinical evaluations according MEDDEV 2.7.1 specification, inter alia
- Review of the present product data
- Preparation of a clinical evaluation plan
- Identification of the present clinical data
- Evaluation and analysis of the data
- Preparation of the evaluation report in german and english
- Early evaluation, whether the clinical evaluation can be prepared in a literature based way, or if a clinical evaluation is necessary
If, within the clinical evaluation, the literature data is found to be insufficient to assess the clinical benefits and risks of your medical device, a clinical trial must be performed.
senetics offers inter alia:
- Consultation for the planning of the studies
- Support in the preparation of a test plan
- Evaluation of the regulatory requirements
- Application for the permission for the higher federal authorities responsible
- Support with the application to the responsible ethics committee
- Statistic data analysis
- Authoring the final report
Enterprises as persons in charge under § 5 Sentences 1 and 2 (MPG) after commencement of activities must designate a person with the necessary expertise and the required reliability as a safety officer for medical devices in order to carry out their duties.
Proof of the required expertise as a safety officer for medical devices is provided by:
- The certificate of a completed scientific, medical or technical university education or
- another training that accepts to fulfill the following 4 possible tasks,
and at least two years of professional experience. The expertise must be demonstrated at the request of the competent authority.
With senetics all mentioned points are fulfilled by specialists with relevant studies, further education and professional experience.
The Medical Device Safety Officer has to collect and evaluate notifications of medical device risks and to coordinate the necessary actions. He is responsible for the fulfillment of reporting obligations as far as medical device risks are concerned.
senetics provides one of its experienced employees as a security officer for your products.
If you are a small or microenterprise, we are happy to provide you with the “Responsible Person for Regulatory Requirements” under EU Regulation 2017/745 (MDR) (Art. 15).