We understand the importance of having a qualified team to navigate the complexities of risk analysis for medical devices and IVDs. Whether you need support at every stage of the analysis or simply require expert oversight, our multi-disciplinary team is here to help. We can step in as a member of your risk analysis team or providing an external guidance offering our regulatory expertise and experience in the diverse world of medical device and IVDs You can rely on us to ensure that all activities are planned and executed in full compliance with the applicable Regulation. We meticulously adhere to technical standards such as ISO 14971:2019 and ISO/TR 24971:2020, guaranteeing thoroughness and accuracy throughout the process.
Our service is invaluable for companies seeking to enhance their team’s capabilities by incorporating external regulatory expertise. Whether you’re looking to bolster your internal resources or require expert guidance to steer you through the risk analysis process, we’re here to ensure everything is done correctly and efficiently.
