Regulatory support in translational biomedical engineering

A success-determining factor in the development of medical devices is the regulatory strategy. The sooner it is defined, the smoother the necessary conformity assessment can be carried out and the faster the product can reach the market. The current European regulations MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) include requirements regarding quality and safety of medical devices and are mandatory for successful market entry.

Manufacturers have to prepare technical documentation to demonstrate general safety and performance requirements. Documented risk management to assess and minimize potential risks as well as clinical evaluation are regulated in detail and essential for compliance. Throughout the life cycle of a product, processes must be in place to identify and assess technical, biological and chemical risks.

The business unit Translational Medical Technology combines expertise in the field of medical devices with many years of experience with the assessment of chemicals, nanomaterials and biocompatibility. We support manufacturers of medical devices in the development of medical technology innovations or adaptation of already existing products to the current requirements as well as in the establishment of a quality management system according to ISO 13485. Risk management is developed in accordance with (DIN EN) ISO 14971, a biological assessment of the medical device is performed as part of the risk management process, and tailored in vitro and in vivo testing is identified and offered. We work with our clients to develop individual strategies for market placement, in line with applicable standards or preclinical testing. Clinical evaluation is primarily literature based and can be completed by clinical testing if required. An extensive database on requirements and materials for optimized (re-)certification of medical devices is under development.