Services

Biological Safety Assessment
Each medical device must undergo a biological safety evaluation to demonstrate its freedom from unacceptable biological risks in the context of its intended use. Biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application. In this context, the biological safety assessment is the process to establish biocompatibility as part of risk management. This process can leverage on chemical and biological tests carried out by qualified and state-of-the-art external laboratories. These can be performed under the coordination of Niu Consulting and with the collaboration of biologists, chemists, material scientists, and toxicologists.

Here are the main services we provide to medical device manufacturers:

• BIOLOGICAL EVALUATION PLAN AND REPORT: the biological evaluation plan considers medical devices as a whole, with particular regard to the type of patient contact and intended clinical use, the potential risks associated with manufacturing materials, the history of clinical use of the manufacturing materials, the manufacturing process, the results of biocompatibility and chemical characterization tests performed on the device, the clinical history of the device and information available in the literature. The biological assessment report is prepared in accordance with the current relevant regulatory standards, and specifically the ISO 10993-1  standard series and the U.S. FDA Guidance on “Use of International Standard ISO 10993-1”. 
• TOXICOLOGICAL AND EQUIVALENCE ASSESSMENTS: the toxicological risk assessment of the chemical ingredients used to produce a medical device includes tests for chemical composition and tests on extractables and leachables. Furthermore, it comprises the assessment of any degradable or leachable material. The biological equivalence assessment of a medical device to a clinically established similar device consists of the evaluation of the chemical, physical and material equivalence of the device under evaluation, in concomitance with the assessment of its clinical and contact equivalence.

Structured approach & quality consulting
In addition to the biological and chemical tests, carried out in collaboration with state-of-the-art laboratories, we follow our clients’ medical devices throughout the complex regulatory phase until they are awarded regulatory approval and put on the market.

The evolution of European legislation and specifically the Medical Device Regulation (MDR) puts more importance on biocompatibility, physical, and chemical characterization of device constituent materials, as well as on the qualification of assessors and reviewers. In addition to the biocompatibility and biological safety of medical devices, we always pay the utmost attention to the accuracy and clarity of the documentation to be produced for regulatory purposes. The knowledge of notified bodies and regulations that we have acquired over the years allows us to formulate with our clients and develop the most effective evaluation strategies. This is in line with current regulatory requirements for a systematic, structured, and stepwise approach to biological evaluation of medical devices that starts from a deep understanding of material and manufacturing processes, the analysis of already available data, and the optimization of the chemical and biological testing strategy for the purpose of guaranteeing the safety of the final manufactured device.



A customized high-quality approach
Regulatory advice as well as biocompatibility and biological safety guidance do not follow standardized checklists. We produce an ad hoc set of assessments around the characteristics of each medical device, which always includes an extensive collection of documents and information at all levels of the company involved, as well as from the scientific literature. The quality of the medical writing that emerges reflects the extensive and in-depth expertise and considerable scientific rigor, excellent prerequisites for a quality medical device.



Product development strategy
Familiarity with the entire development process of a medical device allows us to develop, together with the manufacturer, the best product development strategy. As temporary manager, Chiara Lorenzetto is able to support in managing the development of new medical devices from design through testing and to market launch.