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A fully customized biological safety assessment

The assessment of the biological safety of a medical device is one of Niu Consulting’s key competences. It is a field to which the founder, Chiara Lorenzetto, has dedicated years of work. And it is precisely in this field that the European Union has recently established some important regulatory adjustments that require increasingly stringent compliance.

In fact, the Medical Devices Regulation (EU 2017/745) is replacing the Medical Devices Directive (93/42/EEC), the series of regulations that regulate the access of medical devices to the European Union market. A long-awaited regulation that devotes greater attention to technical documentation, including clinical evaluations, post-market clinical follow-up, and traceability of devices, and the entire supply chain. Also, recently published, is the new ISO 10993-18:2020 (Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process), a regulatory framework aimed at prioritizing an assessment of chemical-physical properties that minimize the use of animals in favor of tests carried out with in vitro models. Also of particular relevance are the specifications that stipulate that a detailed collection of physical and chemical information on medical devices must be carried out. In order to carry out a biological evaluation, it is necessary to identify and quantify the manufacturing materials of a medical device (device configuration), the chemical components in each manufacturing material (material composition), and all chemical substances used in the manufacturing process of medical devices. In addition, the potential release by a medical device and/or its manufacturing materials – chemicals to which the patient concerned may be exposed under clinical conditions of use – must be determined.

The world of medical device regulation is therefore evolving and Niu Consulting is evolving hand in hand with it. The latter is increasingly exploring the details of both the applicable regulations depending on the market of interest and the characteristics of the individual medical device. The tests are carried out by qualified external laboratories and information is gathered by trying as much as possible to build an evaluation set around the medical device, profiled ad hoc from time to time.

Acting as a temporary manager of the manufacturing company, Chiara Lorenzetto supports the company team in the collection of information, structured from the outset according to any changes after the medical device has been put on the market. Within this activity, Chiara Lorenzetto is supported by junior company figures. This is a collaboration that, beyond the development of the individual medical device, contributes to the development of the company’s internal skills.

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Progetti | Niu Consulting | Medical Device Biological Safety

About Me

Chiara Lorenzetto founded Niu Consulting in 2018, after fifteen years of activity in the pharmaceutical and biotechnological field at several Italian companies and a Swiss multinational.

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Chi Siamo | Niu Consulting | Medical Device Biological Safety


Niu Consulting takes care of the biological safety assessment of medical devices according to state of the art international standards and provides a customized high-quality approach.

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Servizi | Niu Consulting | Medical Device Biological Safety


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