For the medical devices industry we provide support for to transition your technical documentation from the medical device directive (MDD) to the medical device regulation (MDR).

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
• Clinical evaluation plans (CEP)
• Clinical evaluation reports (CER)
• Post market clinical 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 CEP and CER