In an ever-changing regulatory landscape, you need a partner who stays on top. genae provides all the regulatory support services to guide you pre- and postmarket.
In order to bring your product to the market, it is mandatory for manufacturers to have a Quality Management System in place. genae can support you with the creation of your QMS based on the ISO13485 or ensure the maintenance.
If you are looking for an expert partner to manage your clinical trial, we’re at your service. As a full-service CRO we support you on all levels and in every step of your clinical research project.
Our Digital Health services, including Data Management, Statistics and cloud-based data management platforms, let you manage, analyze, correlate and integrate your health and research data.
staicy, our digital health data management platform, allows you to connect the dots of your health & research project by managing, analyzing, correlating and integrating your data.