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.
Navigating complex regulations and guidelines requires a solid strategy, accurate data, and effective communication.
Our expertise is dedicated to streamlining the review and approval process for your medical device.
We offer comprehensive regulatory consulting services, including the development of tailored strategies for medical device development, pre-market submissions, and FDA or EU Notified Body reviews.
Our services also include expert interpretation of regulatory requirements, preparation and review of submissions for both US and European markets,
and facilitation of meetings with FDA and Notified Bodies to address regulatory, scientific, or technical issues.
Additionally, we support manuscript drafting, white paper creation, and literature reviews to strengthen your submission. Leveraging strategic partnerships with industry experts, we provide a full spectrum of regulatory services, ensuring your device meets all requirements for successful approval and market entry.
We are committed to providing comprehensive support for your medical device design and testing needs.
By employing the right testing strategies, we help you save valuable time and resources while ensuring the highest standards of quality and compliance.
Our key pre-clinical consulting services include conducting thorough medical device design reviews, assisting with device failure analyses, and implementing corrective actions and solutions.
We also specialize in performing biological safety assessments and toxicological risk evaluations, developing protocols for in vivo studies, and can offer scientific guidance for the design and development of combination products.
Through strategic partnerships with companies specializing in medical device design, testing, and engineering analysis, we can connect you with reliable providers to meet your specific needs with tailored, expert solutions.
Biological safety evaluation is a critical aspect of medical device development, that should be considered as early as possible to make the right design decisions, be demonstrated before using medical device clinically, and continue throughout the entire lifecycle of the device.
The biological evaluation of a medical device is an integral part of the broader risk assessment process. This evaluation involves analyzing a range of factors, including the device constituent materials and packaging, the manufacturing and sterilization processes, the device’s interaction with the human body, and its clinical use.
Given the complexity and scope of this task, it is essential to entrust it to a multidisciplinary and competent team, that should encompass expertise in biology, animal testing, and toxicology to ensure precise interpretation and comprehensive evaluation of the data.
Involving external experts can enhance the process by providing objective insights, ensuring accurate assessment of the device’s biological safety, and optimizing both time and costs associated with the evaluation.
In the area of clinical evaluation, we provide expert guidance to develop a thorough strategy, leveraging both existing studies and new data to ensure your medical device meets all safety and effectiveness requirements for certification.
We provide comprehensive project management and ongoing support, overseeing the entire development process from initial planning to regulatory submission. Our approach is devoted to ensure smooth progress and adherence to timelines.
Our commitment continues beyond certification with non-conformity management, where we assist in addressing and resolving any issues to maintain compliance with regulatory standards throughout the product’s lifecycle.
NIU Consulting S.t.p. S.r.l.
P.IVA 12442090010
Corso Moncalieri, 282
10133 Torino
Design Liquidostudio
