About us
AR2-C2 GmbH began its journey with a vision to bridge the gap between innovative medical device companies and the European market. We are driven by a passion for advancing healthcare, embarked on a mission to simplify and expedite the regulatory entry process into Europe. We are dedicated to enabling medical device startups to realize their potential and impact lives.
Meet the individuals who fuel our mission:
Ronald Boumans
Ronald Boumans – Regulatory Maverick: With extensive experience spanning R&D, distribution, research, certification, standard development, market surveillance, policy-making, stakeholder representation, and consulting, Ronald brings a 360-degree view of the medical device landscape. This unique perspective allows him to tackle challenges from multiple angles, empowering organizations to tailor their strategies and maintain full control over their processes.
Background and Journey: Ronald earned an engineering degree in industrial design from the Technical University of Delft in 1986. His journey commenced in R&D for medical devices, encompassing package design. He transitioned into importing and distributing devices in The Netherlands, followed by groundbreaking quality research that explored the nexus between medical devices and quality of life.
Regulatory Authority:This journey led him to serve as a senior inspector for medical technology at the Dutch competent authority, gaining invaluable insights into regulatory compliance.
Consulting Expertise:In 2013, Ronald joined Emergo as a senior regulatory consultant, further honing his expertise. In 2022, he ventured out to establish his own consulting company, where his out-of-the-box thinking continues to provide precious added value in the field of regulatory compliance.
Nika Mendelev
Nika Mendelev – Quality & Regulatory Maestro:Nika embarked on her journey in the realm of medical devices after graduating in biomedical engineering from Technion- Israel Institute of Technology in 2009. With an insatiable curiosity for innovation, she delved into the field of active imaging, where she served as a developer and scientist until 2012. During this time, she gained invaluable experience in device development, pre-clinical and clinical studies, and the intricacies of pioneering technology.
Shifting Focus: In 2013, Nika redirected her focus towards Quality Management Systems (QMS) and Regulatory Affairs (RA). Her dedication and versatility have allowed her to assume various roles within medical device companies. She commenced her journey as a Quality Engineer and steadily ascended to the role of Quality Manager. This journey has granted her a profound understanding of the industry’s interdisciplinary aspects.
Comprehensive Expertise:Nika possesses a diverse skill set, ranging from medical device development to quality assurance in production. She excels in setting up technical documentation and boasts a commendable track record in auditing—conducting internal, supplier, and notified body audits with precision.
Zeev Vilf
Zeev Vilf – Market Entry Virtuoso: Zeev brings a unique perspective to our team. Having studied Psychology at the University of Erlangen, he embarked on a remarkable journey that spans over three decades. For more than 30 years, he was the founder and manager of a highly successful gastronomy chain, honing his skills in business strategy, customer relations, and operational excellence.
A New Chapter: In 2020, Zeev transitioned his expertise to a new realm. Leveraging his decades of experience in entrepreneurship and management, he has been successfully supporting startups in their quest to enter the European market. His keen understanding of consumer behaviour, market dynamics, and strategic planning has proven to be a valuable asset to our clients.
Leonhard Staerk
Leonhard Staerk: Your Esteemed European Business Advisor: Leonhard is a highly regarded expert in European business dynamics, known for his exceptional knowledge. With a law degree earned from Ludwig-Maximilians-Universität München in 1986 and over 30 years executive experience in international business in the sectors Telecommunications, Air&Space-Industry as well as Health Services, possesses a profound understanding of the intricate European business landscape.
Leonhard brings a deep understanding of healthcare structures, both public and private, in Germany. His insights into the current landscape and future trends in German healthcare are invaluable. With his guidance, you can confidently navigate the complexities of European business and healthcare as you embark on your journey in the market.
Our Values
- Honesty and Integrity: We always act with honesty and integrity in everything we do. Our transparency and ethical approach build trust and confidence.
- Quality Healthcare: Our commitment to advancing healthcare in Europe centers around providing top-quality services. We're dedicated to improving patient care and outcomes.
- Environmental Responsibility: We take our environmental responsibilities seriously. We aim to reduce our impact on the environment through sustainable practices, contributing to a healthier planet.
- Collaborative Partnerships: Collaboration is key to our work with medical device startups. We believe in working together in a friendly and respectful manner, aiming for mutual success while considering the well-being of patients and the environment.