“Our mission is to assist in accelerating successful achievement of their regulatory, clinical and marketing goals."
MedPass operates a full Quality Management System, compliant with ISO 13485. We can therefore perform CE marking trials and develop a clinical QMS for our clients. Our expert team have considerable Notified Body experience with BSI, LRQA, LNE-Gmed, advising on QMS. In 2007 MedPass became the first medical device CRO to be certified to ISO 13485.
- Clinical activities (Study documentation design and review, site qualification, site monitoring, site initiation and close out, …)
- Regulatory Activities (submissions to EC and CA, reporting of adverse events and incidents…)
- Biometrics activities (data handling, database validation, database export, statistical plan, statistical report….)
- Strategic Consulting services (Clinical Evaluation Report, Literature Reviews…)
- Authorized Representative services
- Sites successfully audited by FDA, ANSM, German, Polish and Swiss Competent Authorities
- Approved vendor for Abbott Vascular for compliance with FDA requirements including 21 CFR Part 11.
- Our quality system is regularly monitored through our KPI which includes New business development , Clinical affairs, staff training and customer feedback review.