MDHTA

In cooperation with the CzechHTA team of the Faculty of Biomedical Engineering of CTU we provide the following services:

Need help getting a medical device to market?

We offer:

  • Complete preparation of technical documentation (ZP and IVD ZP) according to relevant regulatory regulations

  • Elaboration of a clinical evaluation or functional capacity assessment from the supplied data

  • Assistance with data collection and evaluation preparation

  • Preparation of a risk analysis, including a benefit/risk ratio

Do you want your product to be part of reimbursements?

We offer:

  • Processing of documents for reimbursement

  • Literature search processing

  • Preparation of budget impact analysis

Your product is already on the market and you need help with post-market tracking?

We offer:

  • Preparation of a post-marketing monitoring plan in accordance with the relevant regulatory provisions

  • Preparation of the post-marketing monitoring report (ZP and IVD ZP)

  • PMCF (Post-Marketing Clinical Follow-up) processing

  • Processing of PMPF (Post-Market Functional Capability Follow-up)

  • Trend report processing

  • Preparation of an updated safety report

Need help with other procedural issues related to medical devices?

We offer:

  • Preparation for certification by a notified body according to a given conformity assessment procedure

    • Preparation of documentation

  • Communication with the notified person

  • Preparation and implementation of standard 13485 for the mandatory introduction of a quality management system

    • Communication with the certification body

    • Preparing for the audit

  • Help with the categorisation of a medical device (ZP and IVD ZP)

  • Assistance with the registration of a medical device (ZP and IVD ZP)