In Vitro Diagnostic

The In Vitro Diagnostic (IVD) team at TFS has experience in managing performance evaluations in compliance with the applicable directives and harmonised standards. We can provide a wide range of medical and scientific services required to support all stages of IVD development.

TFS is able to provide global trial support as well as specific advice on compliance with regional and national requirements.

IVD performance evaluations

  • Study design and protocol development
  • Management and monitoring of performance evaluations
  • Post market performance evaluations
  • Data management and biostatistics
  • Audits of all types of performance evaluations
     

Scientific Support

  • EU clinical evaluation reports (CER) and literature reviews
  • Publications
  • Abstracts
  • Posters
     

Regulatory Support

  • IVD classification
  • CE Mark consulting
  • Selection of and liaison with IVD Notified Bodies
  • Submission of requests for authorisations to competent authority / regulatory authority to
  • Submissions for ethical approvals
  • Technical file or design dossier preparation for obtaining European CE marking
  • Vigilance reporting in Europe

Training

  • Introduction to IVD products (overview of regulations, classification, routes to CE marking)
  • IVD Device Directive