“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.

Certified for full scope of activities

  • 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

Compliance with FDA requirements

  • 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.

Quality Performance Indicators

  • Our quality system  is regularly monitored through our KPI which includes New business development , Clinical affairs, staff training and customer feedback review.

Certifications

MedPass is certified by TUV Rheinland since 2007 and has successfully passed the certification to the latest version of ISO 13485 in January 2018.

MedPass is a registered partner wIth the French Ministry of Research  for supporting research and development organizations in France.

Membership

MedPass is pleased to count among it staff, active members of ISO, giving MedPass a unique insight on the most recent development of the medical devices regulations.

Medpass is a founding member of the European Association of Authorized Representative since 2002