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)