Welcome to the Arazy Group

We are a leading consulting firm specializing in regulatory affairs and product registration for medical devices and IVD products. Our mission is to make the best medical devices and medical practice available to patients and physicians worldwide.

“These times are marked by change and transformation. I encourage everyone involved in bringing Medtech products to market to implement the best practices that leverage modern technology solutions to ensure their products are equally available for everyone most efficiently. I invite you to connect with me on LinkedIn!“

– Benjamin Arazy, CEO

Reflecting on our Journey

With over 25 years of experience, our team has helped thousands of MedTech companies successfully navigate the complex registration processes, providing tailored solutions that meet each client’s unique needs. We work closely with our clients to understand their specific requirements and provide effective and efficient solutions that enable them to gain and maintain market access in multiple countries throughout the product life cycle.

The Arazy Group is the innovator behind the most effective and widely used MedTech regulatory technology products, LICENSALE® – Global MedTech Registration System and REGISLATE® – Global MedTech Registration Management Software (RMS). Used by thousands of regulatory affairs professionals since 2013. These cutting-edge solutions facilitated over 4500 MedTech product registration activities worldwide, significantly reducing the time and cost of gaining and maintaining market access.

We offer services available in 140+ countries worldwide, enabling companies a significant global advantage to gain market access in multiple countries without working with various consultants. We also offer License holder and Authorized Representative services in more than 100 markets, enabling companies to separate their market access activities from commercial activities and control the markets independently from local distributors.

Staying true to our mission to “Make the best medical devices and medical practice available to patients and physicians worldwide,” we are committed to providing personalized, efficient client support. Our dedication to building long-term relationships and establishing ourselves as trusted partners in the MedTech industry has enabled us to provide services to early-stage start-ups and top 100 multinationals, catering to the needs of companies at every stage of development.

Our reputation, experience, and innovative solutions make us a trustworthy choice for companies seeking MedTech regulatory affairs and product registration support. Thank you for considering the Arazy Group for your regulatory affairs and product registration needs.

27 Years Of Experience

2500 Companies Trust Arazy Group

4600 Applications

Elekta, United Kingdom

“Arazy Group’s approach to regulatory affairs and goals with regards to emerging markets are wholly in line with Elekta’s long-term goals. We are able to approach new opportunities with confidence that we can find a solution to the challenge.”

Hanin Medical

“We were very excited to receive our 510k clearance for the SAAD patient monitor months earlier than anticipated with Arazy Group. Arazy Group went above and beyond for this project and we are very happy with the result, which marks the first registration project of its kind in the USA and EU.” – Rudolf Holzhausen, PhD.

Visionsense Ltd.

“Arazy Group has guided us with quality management and registration for over 10 years, obtaining licenses for our devices in the USA, EU, and Canada, with more projects underway. The seamless relationship between our teams has enabled us to maintain our quality management system at a high level and our ongoing cooperation is very fruitful and constructive.” – Azi Ben-Yishai

SPD Swiss Precision Diagnostics GmbH

“Advantages of working with Arazy Group include their expert knowledge of regulatory processes in many markets throughout the world and that they offer a dedicated Arazy Group client manager, acting as a single point of contact with whom we can discuss the progress of ongoing projects and raise specific questions or concerns.”

Luminex Corporation

“Arazy Group has been instrumental in the commercialization of our IVD medical devices. Their expertise has allowed our company to successfully obtain product approval and expand access to our technology in three new markets over the past three years, with three additional markets underway.”