Medical Device Technical Documentation

With you, preparing, completing, collating and maintaining your medical device Technical Documentation to evidence:

  • Intended Use
  • EC  / Country Classification
  • Predicate(s)  / Substantial equivalence
  • Risk Management
  • UDI / Labelling
  • Attainment of ISO / National Standards
  • Device safety & performance
  • Clinical Evaluation
  • Compliance with country specific regulations
  • Declarations of Conformity