Our experts assist you with evaluating the clinical safety and performance of your product and determine its benefits and risks based on the national requirements of your key markets (e.g. Europe, United States, Canada and Brazil).
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.
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.
Depending on your product our clinical experts will perform a comprehensive clinical evaluation or performance evaluation acc. MEDDEV 2.7.1 Rev 4 .This includes for example 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 incl. e.g. clinical /performance evaluation plan, clinical / performance evaluation report, as well as continuously evaluating/reviewing the acceptability of the product’s benefit-risk ratio.
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 incl. e.g. PMS plan and report, periodic safety update report (PSUR), 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.
Our experts with expertise in clinical trial management will 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 fit your needs.
Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!