For the in vitro diagnostic devices industry we provide support for to transition your technical documentation from the in vitro device directive (IVD) to the in vitro device regulation (IVDR).

We specialise in performing systematic and reproducible literature reviews, that comply with MEDDEV 2.7/1 Rev4 and MDCG 2020-13 for:

• The state-of-the-art
• Product design requirements
• Performance evaluation plans (PEP)
• Performance evaluation reports (PER)
• Scientific validity reports (SVR)
• Analytical performance reports (APR)
• Clinical performance reports (CPR)
• Post market performance follow-up (PMCF)
• Post market surveillance (PMS)
• Risk management
• Scientific publications

Our data services assess the quality of data, statistically analyse the data and present your data for internal reports, regulatory documents or scientific publication.

We also provide a subscription services to maintain your PEP and PER