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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.
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.