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How we used a staged qualitative approach to help inform the development of a portfolio of novel digital solutions for GI endotherapy
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.
How we collected Level 4 PMCF data for our client's Class III Peripherally Inserted Central Catheter (PICC) through a high-quality PMCF survey
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
How we informed on customer requirements for a single infusion pump utilizing pre-filled syringes for subcutaneous immunoglobulin therapy
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.
How we collected Level 8 PMCF data for our client's legacy Class I syringe for their EU-MDR submissions
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.