Kounter Intuitive Technologies (KIT)
Founded in 2013, Kounter Intuitive Technologies (KIT) embarked on a mission dedicated to empowering medical device companies in expediting the commercialization of their products.
With an unwavering commitment to excellence, KIT has carved a niche for itself in the dynamic landscape of regulatory affairs and quality management system (QMS) compliance.
At KIT, we recognize the critical importance of seamless navigation through the intricate regulatory pathways governing the medical device industry. Our primary objective is to provide robust support to our clients, facilitating the swift and efficient journey from product development to market launch.
One of our key strengths lies in our specialized expertise in regulatory affairs and quality management systems. We understand the nuanced complexities associated with regulatory frameworks and compliance standards, offering tailored solutions to ensure our clients' products meet the highest industry standards.
We understand that time is of the essence in the competitive landscape of medical device development. KIT is dedicated to streamlining the regulatory and compliance processes, allowing our clients to accelerate the commercialization of their products without compromising on quality or regulatory integrity.
The regulatory landscape can be challenging to navigate, and KIT serves as a trusted guide for medical device companies. Our experienced team excels in interpreting and applying regulatory guidelines, providing strategic insights to overcome hurdles and ensure a smooth path toward market approval.
Quality is the cornerstone of our operations. KIT is committed to upholding the highest standards of quality management, both in terms of product development and manufacturing processes. We work closely with our clients to implement and maintain robust QMS that align with industry best practices.
KIT views every client relationship as a collaborative partnership. We actively engage with our clients, fostering open communication and a transparent working environment. Our goal is to build lasting relationships based on trust, integrity, and a shared commitment to success.
As we reflect on our journey since 2013, Kounter Intuitive Technologies remains dedicated to pushing the boundaries of excellence in regulatory affairs and QMS compliance. We look forward to continuing our support for the medical device industry, contributing to the advancement of innovative healthcare solutions. Empower. Accelerate. Excel. This is the KIT commitment to our clients and the future of medical device innovation.
How we work
Our Team
Chairman
Manager Product Regulatory Compliance
Manager Product Clinical Compliance
Assistant Regulatory Compliance
Assistant Clinical Compliance
Assistant Software Regulatory
Admin Manager
STANPHARMA Ltd., Netherlands
