CRO & IVDR SERVICES
Clinical Research & IVDR
Start with the intended purpose and the evidence available. We support regulatory planning, study operations, medical writing and European representation, as individual services or an agreed programme.
Find the service for your current question
Commission a review, a study or documentation work individually, or coordinate several stages within one project.
IVDR Consulting & CE Marking
Classification, intended purpose, gap analysis and conformity-assessment route.
Performance Evaluation & CRO Studies
Scientific validity, analytical and clinical performance under Annex XIII / ISO 20916.
Technical Documentation & PMS/PMPF
STED, Annex II/III technical files, PMS plans and post-market performance reports.
EU Authorized Representative & PRRC
Article 11 EC-REP and outsourced Article 15 PRRC for non-EU manufacturers.