Certification of Medical Devices

Have you developed product for diagnosis, prevention, monitoring, treatment of disease or injury? Or plan to do so? Well the actual definition is much broader and covers almost any field of potential technology applications in healthcare. So don’t take a chance, contact us to get proffesional advice on how to register your Medical Device both in Europe and in the US.

Our team has succesully completed several certification processes both for large oranisations and for startups. In addition, to the certification process, we support our clients in the preparation of the project plan and manage its execution. We also assist in selecting accredited laboratories and notified body responsible for the final audit.

Typical structure of the certification process of the IIa electronic medical device:

  • Manufacturing medical device, designed in accordance with the standards
  • Literature research for selected diagnostic methods
  • Preparation of technical and system documentation
  • Device testing for compliance with standards
  • Obtaining test reports
  • Initial Audit (first stage): quality system documentation, analysis of documentation by the auditor
  • Final audit (second stage): technical documentation, medical assessment,
  • Submission of the registration at the Office for Registration of Medicinal Products

The time required to carry out the above stages is about 6 months, but each case requires a separate analysis.