Are you looking to develop a safe medical device which is reliable and meets the requirements of regulations and customers within time and budget? 

We are experienced in, amongst others, setting up technical documentation conform MDR (2017/745) and IVDR (2017/746), clinical evaluation, quality management (ISO 13485), and risk management (ISO 14971).

Holland Innovative (HI) can assist you in the development process of your medical product. Our experts have many years of experience in medical product development. They have worked at major medical companies, including multinationals, SMEs, and MedTech start-ups. HI team members have backgrounds in physics, electronics, software, mathematics, technical medicine, and biomedical engineering. Through our integration of Reliability, Design for Six Sigma, regulations, and project management, HI has grown into a highly skilled competence center for the development of medical equipment.