As part of contract research, we offer you 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)