Regulatory compliance

Based on your development project and the regulatory strategy defined, we support you in all your medical device’s development stages.

  • Support and drafting of the medical device’s specifications
  • Development procedures including software development procedure (Standard EN 62304)
  • Risk analysis (Standard EN ISO 14971)
  • Responses to performance and safety requirements
  • Identification of harmonized and/or recognised standards to be taken into account
  • Clinical strategy and clinical trial applications
  • Clinical data evaluation files according to the MEDDEV or IMDRF guidelines that apply
  • Verification and validation of the device
  • Drafting of regulatory technical dossiers
  • Submission of CE marking or certification applications

It is important to take proper account of all the requirements relating to medical devices or in vitro diagnostic medical devices from the initial design phases.