Medical device products
Medical devices
Medical devices are a wide range of products that require a tailored approach when it comes to generating the required clinical evidence. Scandinavian CRO can support you in developing a clinical development strategy for your medical device, as well as conducting pre-market clinical investigations, clinical evaluations, and post-market clinical follow-up activities.
Dedicated
medical device experts
At Scandinavian CRO, we have the medical device expertise to help you with all aspects of your clinical investigations from planning, designing and executing through to analysis and reporting. We have extensive experience with all types of clinical investigations including first-in-human studies, feasibility or pilot studies, randomized controlled clinical investigations, and registry studies. We can also support you with your clinical evaluations, as well as partnering with you to build the right clinical development strategy for your medical device.
SCRO services for medical devices
Pre-CE clinical investigations
Clinical investigations are clinical studies in human subjects that assess the safety and/or performance of a medical device. Prior to starting a clinical investigation, it is important to assess the scope of the investigation and whether it is needed at all. A pre-CE clinical investigation is often the cornerstone of evidence that proves your medical device is ready to enter the market. Data from the clinical investigation becomes input for your clinical evaluation.
Clinical evaluations
The clinical evaluation, documented in the clinical evaluation report (CER), is the process of collecting, evaluating and analyzing the clinical data for a medical device. The CER is used to assess whether there is sufficient clinical evidence to confirm compliance with regulatory requirements for safety and performance when using the medical device in accordance with the manufacturer’s instructions.
Post-market surveillance
Post-market surveillance (PMS) is a regulatory requirement for continuously evaluating the safety and performance of medical devices on the market. A PMS plan is a critical document that describes PMS activities such as your post-market clinical follow-up (PMCF) methodology and activities. A PMCF collects and assesses clinical data about the safety and performance of a marketed medical device in order to update its clinical evaluation.
