Our client’s device is used for a specific indication, however users identified a potential benefit of the device’s design to perform for another indication. This study differs from typical PMCF efforts, with an aim to update the device’s labelling (IFUs) with safety and feasibility data for the expanded use. Find out how we heled out client in collecting retrospective real-world data to support the indication expansion.

Find out how we used a staged qualitative approach to help our client understand the landscape of digital solutions in GI endotherapy with a focus on AI, data management (clinical and non-clinical), workflow, and supply management.

A leading medical device manufacturer required Post Market Clinical Follow-Up (PMCF) data for their Class III Peripherally Inserted Central Catheter (PICC). This clinical evidence was needed to comply with PMCF data collection under the MDR

Find out how we provided our client with a clear and effective path forward to help launch their pre-filled syringes for subcutaneous immunoglobulin therapy, and how best to position themselves for widespread adoption.

A leading medical device manufacturer required Post Market Clinical Follow-Up (PMCF) data for their legacy Class I syringe. This clinical evidence was needed to comply with PMCF data collection under the EU-MDR. Find out how our PMRC survey approach strengthened the regulatory compliance for their device.