IVD Device Compliance

Home Services Quality Assurance IVD Device Compliance

Any questions you may have regarding the clinical evidence and technical documentation of your IVD can be answered by MedWatch Global with competence.

Technical Reports and Medical Evidence

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

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.


Medical writing & surgeons

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

Medical in vitro diagnostic equipment is a specialty of MedWatch Global. 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