MEDICAL DEVICE
CONSULTING SERVICES

Our mission is to provide our clients with top-quality
services that are customized to their specific needs,
ultimately empowering them to bring safe and
effective
devices to the market.

WHO WE ARE

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.

 

REGULATORY
CONSULTING

In healthcare, a solid regulatory strategy is key to bringing new drugs, devices, or technologies to market.
Niu Consulting offers a comprehensive support, from development of comprehensive regulatory strategies to hands-on support in technical writing.
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PRECLINICAL
CONSULTING

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.
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BIOLOGICAL
SAFETY ASSESSMENT

We specialize in the biological safety assessment of medical devices, offering end-to-end support from strategy definition to testing coordination and documentation, including Biological Evaluation Plans and Reports, and Toxicological Risk Assessment.
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FROM DESIGN DOSSIER
TO CERTIFICATION

Niu Consulting covers all phases of medical device development, from design, through validation, certification, up to post-market surveillance. Our experience and expertise guide you through the challenges of product development and certification, turning challenges into opportunities for success.
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A PROFESSIONAL TEAM

We are a team of high specialized professionals, and can count on an extensive network that includes free lance consultants with expertise in specific areas, international consulting companies and key opinion leaders.

Chiara Lorenzetto

Founder and Principal Consultant

Giulia Bassani

Senior Consultant

Camilla Bernori

Senior Consultant