Technical Documentations and Clinical Evidences

Home Services Clinical Interventions Technical Documentations and Clinical Evidences

Any query or requirement relating to the clinical evidence and technical documentation of your IVD can be handled by our experienced and competent device compliance team.

Do you require assistance in creating your IVDs’ Technical Documentation in order to meet with DRAP?

  • Do you need professional guidance on potential clinical proof tactics for your IVD?
  • Or do you want your Technical Documentation to be thoroughly evaluated before you send it to a Notified Body (NB)?
  • Any query or requirement relating to the clinical evidence and technical documentation of your IVD can be handled by our device compliance team due to their experience in this area.

OUR SERVICES FOR DEVICE COMPLIANCE

Expert writings and medical advice

Many IVD manufacturers must go through a time-consuming document writing procedure in order to comply with the new IVD regulation.

MedWatch Global is an authority on medical instruments for in vitro diagnosis. We can assist you with tasks related to medical writing or provide ad hoc expert advice:

 

  • STED compilation (Summary of Technical Documentation)
  • STED review and gap analysis
  • Clinical evidence documentation written by medical professionals, including performance assessment plans and reports, as well as analytical and clinical performance reports
  • Proof of the validity of science
  • Summary of effectiveness and safety
  • Ad-hoc advice on issues related to clinical data