What we do
Together, we develop a clear strategy, planning and cost proposal for the clinical study or post-market clinical follow-up (PMCF) activity you would like to outsource to our team. Our team is fully ISO14155 trained and we work in accordance with ISO9001 and ISO14155 compliant QMS. We ensure GCP (ISO14155) compliance in a practical way.
“Our clinical team gained experience working at Notified Bodies, CRO’s and sponsors/manufacturers. This combination of different backgrounds, combined with Qserve’s in-depth knowledge of regulatory affairs creates efficient and compliant clinical trials. “
Qserve’s team has extensive awareness of medical writing, data analysis and broad experience as writers of CEP’s and CERs, we can support any medical device manufacturer. Contact us and our team will answer all your questions about our services, solutions and budgets.