Defining the clinical investigation strategy and subsequently compiling the clinical investigation report in accordance with GCP ICH E6, FDA 21 CFR part 50, 56 and 812; as well, supporting the compilation of the technical file to obtain FDA clearance of an exoskeleton within three months.
Restructuring the risk management process and documentation, to increase efficiency, to enable risk-based product development, and to ensure alignment with present-day quality and regulatory requirements, including the international standard ISO 14971.
Establishing and mapping the clinical evaluation process as well as clinical investigation process in accordance to the current regional (i.e. FDA 21 CFR, EU Medical Device Regulation (MDR)) and international regulatory requirements in alignment with ISO 14155
Revision of the Product Technical File (process, contents, presentation, structure), to increase compilation efficiency and to ensure alignment with current standards, regulations (i.e. MDR) and "State of the Art" requirements
Coaching small companies & start-ups to use a lean approach, to expediate market access of their products
Supporting EU notified bodies in auditing and educating their customers.