Regulatory Affairs as a new service

Together with new competencies and experience of our enlarged team, we support the set up of a robust quality management system (QMS) complying the regulatory requirements in the field of medical devices. Our clients will decide, which form of support they’ll need: regulatory gap analysis, consulting, mentoring or even complete preparation of technical documentation. Because the regulatory affairs are essential in any innovative health projects, we are certain to bring even more value to our clients.