Niu Consulting was founded in 2018 with the aim of providing medtech customers with high quality consultancy services, particularly in the field of innovative products and/or highly complex projects.
Our work is driven by an unwavering commitment to excellence. We approach every project with meticulous attention to detail, ensuring that no aspect is overlooked.
This dedication, combined with our passion for delivering the highest standards, often makes the crucial difference in achieving exceptional results. By prioritizing rigor and precision, we help our clients navigate challenges and achieve their goals.
Competence is about recognizing that no one knows everything, but success comes from assembling the right individuals with deep expertise for each specific aspect of a project. Our approach is centered on this principle.
Teamwork between experts with diverse knowledge often makes the real difference, leading to thoughtful and non-obvious solutions and exceptional results.
Our services are defined by meticulous attention to detail and a tailored approach to meet the specific needs of each project. Our methodology emphasizes constant integration with the client’s team, ensuring seamless and effective collaboration. When needed, clients perceive us as an extension of their own team, while each consultant is backed by our dedicated internal team, offering additional expertise and support to ensure the best outcomes. This approach allows us to tackle the most complex challenges while maintaining the highest professional standards.
We specialize in delivering consulting services that tackle the challenges inherent in developing and certifying medical devices. From navigating regulatory complexities to addressing unforeseen obstacles, our expertise ensures effective solutions at every stage of the process.
With a flexible approach, we adapt to the unique needs and dynamics of each project, providing tailored support that evolves as challenges arise.
Founder and Principal Consultant
Chiara brings more than 20-year experience in new medical device and pharmaceutical product development. She led several cross-functional teams focused on the development of new and innovative products from idea generation to product launch on the market. Chiara has scientific-technical background in biotechnology and holds the qualification to the profession of Biologist. She supports and advices companies as industry recognized expert in biological safety assessment, material/chemical characterization, and toxicological risk assessment. She provides regulatory expertise... in medical device development and created a network of professionals with extensive experience in R&D, regulatory affairs and quality assurance from an industry perspective that can support clients in addressing the multitude of needs of medical device industry. Chiara is Jury Member for the European Innovation Council and work as Expert for the European Innovation Council and SMEs Executive Agency. Since founding Niu Consulting in 2018, Chiara has worked with a wide range of medical device companies world-wide as well recognized consultancy firms specializing in regulatory aspects for medical device approval, in Europe and US markets.
Senior Consultant
After a degree in Medical Biotechnology and Molecular Medicine and a PhD in Medical Physiopathology, Giulia specialized in translational research focusing on preclinical and regulatory strategy. From researcher to Regulatory & Biological safety consultant, with 7 years in new medical devices development and 10 years in the design of preclinical studies, she assists companies looking for the most effective path to validate their products with focus on the biological safety of medical devices. Starting from regulatory requirements definition and biological safety assessment, Giulia designs the appropriate on-bench, in vitro, and in vivo studies needed to create peer approvable evidence of the efficacy and safety of medical devices. She also supports companies in writing and reviewing the technical documentation required to certify their products and acts as Project Manager to assist in the rapid transfer of results from bench to bedside.
Senior Consultant
Camilla is a Biomedical Engineer. She graduated with a Master’s Degree - First Class with Honours from Cardiff University (UK) in 2020. Since then, she worked as a consultant for several clients working in the Regulatory and R&D departments. She is specialised in professional technical writing and review of the documentation for both marketed and newly developed medical devices in order to certify and place on the market the devices in Europe, US and other countries (APAC). She has also experience as an R&D project leader for sustainability projects and for the transition from MDD to MDR.
Backed by a team of skilled professionals and a results-oriented mindset, we prioritize quality, efficiency, and meticulous attention to detail. Our goal is to build strong and lasting partnerships, helping our clients achieve success by delivering customized and dedicated solutions.
Regulatory
consulting
Preclinical
consulting
Biological safety
assessment
From design dossier to
certification
NIU Consulting S.t.p. S.r.l.
P.IVA 12442090010
Corso Moncalieri, 282
10133 Torino
Design Liquidostudio
