Regulatory competence enhancement for the validation phase of innovative robotic aids

Purpose and goal:

The project aimed to increase the company´s expertise in clinical evaluation and literature study. Expertise was brought in to support the company in producing an Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) as well as carrying out a so-called state of the art evaluation. The latter was carried out, according to the EU regulations for medical devices, MDR, by an expert with clinical knowledge.

The goals of strengthening competence for future project as well as the implementation of the data collection and writing of CEP and CER are considered to be well met. Expected results and effects:

Through the project and the expert support, the company´s internal competence in the area increased. The key people in the company can now carry out similar projects independently in the future. The project also resulted in the creation of documents that can be used as templates for future project, which strengthens the organization.

For future project, the company will be able to carry out the work largely independently and that the project has contributed to the company building a good relationship with the expert and the clinician for further skills exchange in the future as well. Approach and implementation:

During the project´s initial phase, the company presented the technology and the company´s regulatory work so that the expert would get a good idea of the company´s situation and product. Afterwards, contents were mapped together for Clinical Evaluation Plan before the clinician began the literature study. The Clinical Evaluation Report was carried out together and the content was based on Tendo´s and the clinician´s input as well as the expert´s knowledge of MDR and relevant standards. The work was carried out entirely remotely, which worked well due to the nature of the project.