Key to establishing safety and performance of your product.
Global assistance with establishing safety and performance of your medical devices and IVDs
- Development of a customized strategy for your products and markets
Together with your product experts, we will build a strategy that fits your needs and time lines. Our experienced clinical safety team will guide you in the communication with notified bodies and national authorities.
- Data gap analyses
A systematic and extensive data gap assessment of your clinical and risk management documentation will create the basis for our activities to enable a smart transition to the new regulations.
- Establishment of a profound clinical evaluation/performance evaluation
Depending on your product our clinical experts will perform a comprehensive clinical evaluation or performance evaluation according to MEDDEV 2.7.1 Rev 4. For example, this could include the systematic screening and assessment of scientific literature and data from competent authorities (e.g. FDA, BfArM). Our experts will create all necessary plans and reports including clinical/performance evaluation plans and clinical/performance evaluation reports, as well as continuously evaluate/review the acceptability of the product’s benefit-risk ratio.
- Development of an overarching post-market surveillance (PMS) strategy
Considering your business structures, we will set-up a complete PMS strategy to enable continuous PMS activities that will work for you. Our Clinical Safety team creates the required plans and reports including PMS plan and report, periodic safety update report (PSUR), as well as post-market clinical/performance follow-up plan. For this purpose, our experts will systematically screen scientific literature, databases of competent authorities as well as user feedback. We will support you in implementing the results, updating your documentation and in continuously improving your PMS activates.
- Support in the set-up of clinical trials and post-market studies
With expertise in clinical trial management, our team can help you to define your study goals and develop a clinical strategy. Depending on your target markets and population, we will identify feasible study sites and clinical research organizations (CRO) that will best fit your needs.