Clariscience provides Companies with a multi-disciplinary team to support them in conducting risk analyses of medical devices and IVDs. We can intervene in one or more stages of the analysis, either directly as a team member or as an external guide, offering our regulatory expertise and experience in the diverse world of medical devices and IVDs. We will ensure that the requirements of the applicable Regulation have been correctly applied from the planning of activities to final reporting and that due consideration has also been given to the technical standards ISO 14971:2019 and ISO/TR 24971:2020.
The service is useful for companies that wish to further qualify their team by including external regulatory expertise and/or are looking for expert guidance to lead them through the risk analysis process to ensure that it is implemented correctly.
