Our R&D team is comprised of a diverse group of professionals, including scientists, engineers, and technicians with expertise in various fields such as material science, physics, chemistry, pharmacology, and engineering.
Our team is capable of supporting a broad range of knowledge areas, including exotic metals, drugs, and polymers, as well as manufacturing technology and the development of unique class-III hybrid medical device manufacturing equipment.
A Place Where Ideas Thrive
The Medinol Group’s strategy centers around transforming an idea into a medical product which necessitates a distinctive range of in-house capabilities that facilitate its development at every stage.
R&D
Medinol Group’s R&D team is diverse and capable of supporting various knowledge areas including exotic metals, drugs, and polymers, as well as the development of unique medical device manufacturing equipment.
R&D Team
Mechanical & Analytical Laboratory
Our Mechanical and Analytical laboratory boasts state-of-the-art technologies such as SEM and fatigue testing, 3D printers, laser cutting, silicone castings, and more, which enables us to verify and release medical devices to our customers.
Additionally, our laboratory develops drug release test methods and instruments, new technologies and equipment to support various departmental needs.
Additionally, our laboratory develops drug release test methods and instruments, new technologies and equipment to support various departmental needs.
Materials Department
The Materials department specializes in Nitinol, CoCr alloys, stainless steel, and polymers.
We perform mechanical and analytical testing of materials in compliance with relevant FDA, EU MDR, ISO, and ASTMs requirements.
We perform mechanical and analytical testing of materials in compliance with relevant FDA, EU MDR, ISO, and ASTMs requirements.
Stent Department
Our Stent and Stent Delivery teams are responsible for developing innovative medical devices used in treating various vascular diseases.
Our R&D team designs revolutionary coronary and peripheral stents and their delivery systems, ensuring that they meet safety and efficacy standards and enable physicians to deliver stents more safely and effectively.
Our R&D team designs revolutionary coronary and peripheral stents and their delivery systems, ensuring that they meet safety and efficacy standards and enable physicians to deliver stents more safely and effectively.
Engineering & Process Department
The Engineering and Process Department is focused on developing cost-effective and scalable processes for high-volume manufacturing. Our multidisciplinary team includes specialists in NPI and process qualifications and optimization, with a focus on novel automated equipment development to enhance our process capability.
We use our expertise in Nitinol processing and state-of-the-art automated equipment to support our product development and shorten our time to market.
We use our expertise in Nitinol processing and state-of-the-art automated equipment to support our product development and shorten our time to market.
Clinical
Medinol Group’s Clinical Department successfully conducts global clinical trials, advancing medicine and providing state-of-the-art treatments with commitment to patient safety.
The Clinical Department at Medinol has been at the forefront of medical research for over two decades. With numerous successful clinical trials, our department has played a significant role in advancing the field of medicine.
Our clinical expertise spans various disciplines including coronary vascular, endovascular, and structural heart, enabling us to provide state-of-the-art treatments to patients.
We take pride in our global reach, having conducted trials in multiple regions such as the USA, Europe, Japan, Israel and Brazil with thousands of patients benefitting from our research. Our highly skilled team of professionals is dedicated to advancing the boundaries of medical knowledge with a commitment to patient safety throughout all clinical trials.
Quality
Medinol Group’s Quality Management System ensures our coronary stents meet the highest safety, efficacy, and reliability standards, using a risk-based approach to proactively address issues and continuously improve.
As a developer and manufacturer of coronary stents, Medinol’s advanced Quality Management System is critical in ensuring that our products meet the highest standards of safety, efficacy, and reliability.
The quality management system is designed to comply with the most stringent regulatory requirements and it covers every aspect of the product development and manufacturing processes, from design and testing to the finished product and post-market surveillance.
FDA’s
Quality System
Regulation
ISO 13485
By using a risk-based approach in our quality management system, we can proactively identify and address potential risks before they become issues. We are committed to maintaining a strong focus on risk management and to continuously improving the quality management system to ensure that our products meet the needs of patients and healthcare professionals alike.
Regulatory
In the Medinol Group, the Regulatory Affairs department is tasked with ensuring adherence to relevant global regulatory standards.
In the Medinol Group, we recognize the importance of complying with current regulatory requirements to ensure the safety and efficacy of our medical devices for patients. To fulfill this obligation, we are dedicated to keeping abreast of the most recent regulations and guidelines.
Our Regulatory Affairs division has substantial expertise in registering medical devices in different geographic zones such as:
USA
Europe
Japan
Korea
Brazil
With a successful track record in navigating the intricate regulatory environment, we ensure that our products comply with all mandatory regulations, are safe and efficient for patients, and can be introduced to the market successfully.
With a focus on quality and innovation, we are dedicated to advancing the field of stent manufacturing and improving patient outcomes.
Manufacturing
Medinol Group designs and manufactures high-quality stents using innovative techniques and materials to improve patient outcomes. Our expert team provides customized solutions that meet customer needs.
At Medinol, we specialize in designing and manufacturing high-quality stents for the medical industry.
State-Of-The-Art Manufacturing Capabilities
Medinol's stents meet the most rigorous standards for safety and efficacy.
High-Capacity Production Facility
Our high-capacity production facility enables us to produce stents in large volumes, without compromising on quality.
Committed To Innovation
Our team of experts is constantly exploring new materials and manufacturing techniques to improve our products and production processes.
Customized Solutions
We deliver customized solutions that meet the unique needs of our customers.
