Since 1996, A. Stein Regulatory Affairs Consulting, led by Ms. Ahava Stein, has offered the full spectrum of regulatory consulting for medical devices, from FDA clearance and approvals to CE certification under MDR/IVDR, as well as other global markets. Our team of experts combines creativity with proactive thinking to serve a diverse client base, earning a reputation for uncompromising quality, meticulous detail, and thoroughness.
Recognized as Israel’s leading regulatory affairs firm specializing in FDA and CE submissions and documentation, we bring broad device experience and a proven track record guiding clients through FDA pathways and CE certification. Our work with global manufacturers positions us among industry leaders, with clients including BrainsWay, Mazor Robotics/Medtronic, AEYE Health, Siemens CAD and many more.
Our commitment to rigorous quality standards has earned us an industry-wide reputation for unparalleled thoroughness and attention to detail. We approach each project with a deep technical understanding of the client’s product and proactively advocate for the optimal FDA submission and clinical trial strategy, delivering full approvals and certifications in the shortest feasible timelines while upholding rigorous compliance.
A. Stein Regulatory Affairs Consulting adds value through full-spectrum regulatory management and strategic consulting, empowering clients to anticipate regulatory trends and achieve timely, compliant market access worldwide.
Our profile covers registration, clearance, and approval processes for medical devices by FDA, EU regulators (Notified Bodies), Israeli MOH and other major regulatory authorities (Japanese PMDA, Chinese NMPA, etc.).
Senior regulatory affairs leader with more than 25 years of direct FDA and Notified Body engagement, specializing in all major regulatory pathways including 510(k), De novo, PMA, and IDE submissions.
Over 17 years of experience with profound knowledge of FDA and CE regulatory frameworks. Possesses in-depth expertise from regulatory strategy development through post-marketing compliance.
Senior Regulatory & QA Consultant with extensive expertise in CE MDR/IVDR requirements and quality systems and manufacturing compliance with over 25 years of experience.
Clinical Studies Director with over 20 years of comprehensive experience managing complex multicenter trials, including protocol development, EDC setup and managing a team of CRAs & Data Managers.
CEO and Senior Regulatory, Clinical & QA Consultant
Ahava Stein is a senior regulatory affairs, clinical, and quality assurance leader with more than 25 years of direct FDA and Notified Body engagement. She specializes in FDA and CE submissions and medical device documentation, encompassing all major regulatory pathways (510(k), De novo, PMA, IDE, Q-Sub, 513(g), and RFD) and has participated in PMA Panel meetings. Ahava has managed multicenter, global clinical studies and contributed to regulatory clearance efforts through numerous BIMO inspections, including clinical site visits in the US, Europe, and Israel, as well as sponsor inspections. She also brings extensive experience implementing QA systems for medical device companies, preparing PMA clinical, non-clinical and manufacturing sections, and supporting QMSR and ISO 13485 inspections by FDA and European Notified Bodies. As CEO of A. Stein – Regulatory Affairs Consulting Ltd., Ahava leads a firm renowned for its deep regulatory expertise in FDA and CE submissions, a broad device portfolio, and a track record of guiding clients through the complex FDA regulatory landscape with a commitment to thoroughness, quality, and detail spanning more than three decades.
Ahava holds a B.Sc. in Biology from Bar-Ilan University and has completed several years of medical studies towards an MD at the Technion – Israel Institute of Technology.
Head of Regulatory Affairs Department
Dr. Amit Goren brings over 17 years of extensive experience across a range of medical device industries, with a strong focus on Regulatory Affairs, Quality Assurance, and Clinical Research Management. Since joining A. Stein – Regulatory Affairs Consulting in 2014, Dr. Goren has played a key role in delivering strategic regulatory consulting services to medical device companies, by combining broad regulatory insight with hands-on practical experience in medical device regulation and clinical studies. Dr. Goren possesses in-depth expertise across the entire medical device regulatory lifecycle, from regulatory strategy development through post-marketing compliance. He has profound knowledge of FDA and CE regulatory frameworks and substantial experience preparing and submitting regulatory documentation to the FDA, including Premarket Notifications (510(k)), De Novo Requests, Q-Subs, and IDEs. In parallel, he has extensive experience in preparing Technical Documentation and managing interactions with Notified Bodies for CE certification. Highly familiar with ISO 13485 and medical device design and development requirements, Dr. Goren has supported numerous companies from initial concept through commercialization. His work includes defining precise validation and verification plans to ensure the development of safe, effective, and compliant medical products. In addition, Dr. Goren is highly qualified in the design and implementation of clinical and pre-clinical studies. His expertise extends to medical device quality assurance environments, risk management, Quality Management Systems (QMS), and QMSR requirements.
Dr. Goren’s experience spans a wide range of medical fields, including neurology, cardiovascular devices, in vitro diagnostics, gastrointestinal applications, general surgery, aesthetics, and more. Prior to joining A. Stein – Regulatory Affairs Consulting Ltd., Dr. Goren held regulatory and clinical project management positions at Lumenis, Medgenics, Enzymotec, and PPD.
Dr. Goren holds a Ph.D. from the Technion – Israel Institute of Technology, in Biotechnology and Food Engineering.
Head of Quality Management Department
Moshe Rosenberg brings 25 years of experience in quality and regulatory affairs in medical devices. His background ranges from neurostimulators to infusions pumps, from dental implants to cardiovascular implants, as well as various methods of sterilization. His experience includes clean rooms (Class 7/8), from planning and construction to operating and maintenance. Moshe specializes in FDA and CE submissions and medical device documentation, as well as implementing, maintaining and upgrading of quality management systems in compliance with a broad range of regulatory requirements (CE, FDA, MDSAP, NMPA, etc.). He has extensive experience in Notified Body communications, enabling companies to achieve CE certification for all types of classes, including Class III devices with medicinal substances. Moshe is a certified Lead Auditor for ISO 13485 (BSI), highly skilled in performing internal and supplier audits. He is also a registered Radiation Safety Officer.
Moshe holds a master’s degree in law from Leiden University (The Netherlands), specializing in international and health law.
Prior to joining the A. Stein team, Moshe held senior QA and RA management positions at Tzora Active Systems Ltd., Tyla Medical Ltd., Biometrix Ltd. and Initia Medical Ltd. (Direx Group).
Moshe is fluent in English, Hebrew, Dutch and German
Head of Clinical Studies Department
Adi Rachelson brings over 20 years of experience leading and managing medical device clinical trials across a broad range of therapeutic areas, including respiratory medicine, obstetrics and gynecology, psychiatry, urology, breast cancer, cardiology, ophthalmology, aesthetics, and more. Her expertise spans software, hardware, AI-driven, and combination medical devices.
Since joining A. Stein Regulatory Affairs Consulting Ltd. in 2018, Adi has been leading the Clinical Affairs Department, managing a highly skilled team of clinical research associates and database managers. In this role, she holds full responsibility for the operational excellence and regulatory compliance of clinical trials, with extensive expertise in ISO 14155, ICH E6 Good clinical practice and other international medical device standards.
Adi has extensive hands-on experience in site selection and budget negotiations; protocol development and essential trial documentation; preparation of clinical trial submission packages; site initiation visits and staff training; clinical monitoring; data management and analysis; and the preparation of clinical study reports supporting FDA and CE submissions. She also has significant experience in the planning and execution of Human Factors and Usability Engineering studies for medical devices.
Known for her strong communication skills, Adi maintains close, direct collaboration with global clinical site teams, including principal investigators, study coordinators, technicians, operators, and raters, ensuring high-quality data and efficient trial execution.
Prior to joining A. Stein, Adi held senior clinical and regulatory affairs roles at Remon Medical Technologies Ltd., Real Imaging Ltd., and Hospitech Respiration Ltd.
Adi holds a B.Sc. in Biomedical Engineering from the Technion – Israel Institute of Technology, an M.Sc. in Materials Science and Engineering from Tel Aviv University, and an M.H.A. in Public Health and Health Systems Management from Bar-Ilan University.
Let’s discuss how we can accelerate your path to global market access with clarity, efficiency, and consistent compliance.
Contact A. Stein Regulatory Affairs Consulting Ltd.
Address: 18 Hata’as St. Kfar Saba, ISRAEL , 4442518.
Phone: +972-9-767-0002
Email: office@asteinrac.com