The new clinical research offering complements Labquality’s services in the field of medical device quality and regulations. Labquality’s vast expertise in medical devices enables the preparation and organization of clinical trials for its customers. The solid foundations of clinical research are built on Labquality’s holistic understanding of medical device regulations and on the value chain from product development to commercialization and post-market surveillance. Labquality emphasizes the importance of planning and designing the clinical studies already in the early stages of the product development phase.
‘Clinical research services expand our offering to medical device companies. Our customers will now achieve even greater benefits from our expertise in the medical devices value chain from product development to post-market surveillance. And all this is topped with our strong MD regulatory affairs experience.’ says Labquality’s CEO Juha-Pekka Nuutinen.
Manager of Clinical Research, Hanna Marttila, will be heading Labquality’s clinical research services. She possesses a robust and holistic experience and knowledge of clinical research from startups to larger organizations as well as from public organizations. ‘The new EU IVD regulations oblige more medical device manufacturers to conduct clinical investigations, and therefore, it is important to plan and design the research to efficiently give answers to the right questions. It is also vital to define the research requirements and objectives at the early stages of the product development phase in order to avoid unnecessary mistakes and additional costs. Planning and conducting clinical research is a demanding process,’ says Hanna Marttila.