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 MDR and IVDR (In Vitro Diagnostic Regulation) directives provide standards for the quality and safety of medical devices and are mandatory for successful market entry and approval.

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. Manufacturers of medical devices find comprehensive support in the development of medical technology innovations or the adaptation of already existing products to the new requirements through our certification 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 regulatory strategies, 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.

The EU-wide Medical Device Regulation (MDR) sets out obligations for medical device manufacturers that require more effort and costs to comply with the legislation. Our pooled expertise at Fraunhofer ITEM offers comprehensive support in the implementation of the regulation.

Fraunhofer ITEM provides optimum support in developing innovative biomedical engineering solutions based on compliance with and implementation of the regulations and requirements.

We offer risk management according to (DIN EN) ISO 14971, biological assessment of the medical device as part of the risk management process and tailored in vitro and in vivo tests. Together with our clients we develop individual regulatory strategies, with applicable standards or preclinical tests. 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.

Manufacturers of medical devices find comprehensive support for the development of medical technology innovations or the adaptation of already existing products to the requirements through our certification according to ISO 13485.