Our Mission is to turn complexity into a clear regulatory path for medical innovation
Since 1996, A. Stein Regulatory Affairs Consulting has offered the full spectrum of global regulatory consulting for medical devices, from FDA clearance and approvals to CE certification under MDR/IVDR, as well as Israeli AMAR, Japanese PMDA, Chinese NMPA and more.
From early feasibility through post-market compliance, our team shepherds projects from concept to market through Regulatory Submissions, Clinical Study Management, and Quality Management with meticulous attention to detail, to keep you compliant worldwide.
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 experience covers
AI Software Diagnostic devices (Diabetic Retinopathy, Stent placement, early detection of breast cancer, etc.)
Treatment of Mental Disorders (Transcranial Magnetic Stimulation)
Cardiovascular Devices (IVC Filter)
Aesthetic Treatments (circumferential reduction, skin rejuvenation, wrinkles, acne, etc.)
Robotic Navigation (orthopedic tools/implants)
Erectile Dysfunction (thermal treatment)
Oncology (hyperthermia combined with chemotherapy for treatment of bladder cancer) and more.
Led by Ahava Stein, 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.
Our approach delivers clarity, efficiency, and consistent compliance worldwide. Navigate FDA, CE MDR/IVDR, Health Canada, Israeli AMAR, Japanese PMDA, Chinese NMPA, and other markets with streamlined planning, risk-based approaches, and faster first-pass approvals.
Navigate FDA, MDR/IVDR, Health Canada, Japanese PMDA, Chinese NMPA, and other markets with streamlined planning, risk-based approaches, and faster first-pass approvals.
Outcome: Reduced cycle times and increased likelihood of successful submissions.
Design protocols, manage trial execution, and produce robust clinical study reports with secure EDC to support submissions and ongoing surveillance.
Outcome: High-quality data for regulatory submission and post-market decisions.
Build and maintain a QMS tailored to device design control and manufacturing, ensuring traceability and preparedness for regulator inspections.
Outcome: Consistent quality, compliance, audit readiness, and smoother inspections.
Recognized as Israel’s leading regulatory affairs firm specializing in FDA and CE submissions, with clients including global manufacturers
Deep technical understanding combined with proactive advocacy for optimal FDA submission and clinical trial strategies
Industry-wide reputation for unparalleled thoroughness, rigorous compliance, and attention to detail in every project
Average reduction in multi-market submission timelines
Higher likelihood of successful first-pass regulatory submissions
Decades of regulatory expertise and industry leadership
Ahava Stein provided outstanding regulatory leadership and support throughout our FDA clearance process at Mazor Robotics. Thanks to their deep expertise, hands-on guidance, and highly constructive collaboration with our team, we achieved FDA clearance in just 45 days—well ahead of the typical 90-day timeframe. Their ability to coach, anticipate challenges, and manage the regulatory front with rigor and efficiency gave us the confidence to keep building the business, knowing we were in exceptionally professional hands. We view Ahava Stein as a true strategic partner, not just a regulatory consultancy.
I am pleased to recommend Ahava Stein based on nearly two decades of close collaboration. BrainsWay worked with Ahava since 2007, and throughout this time she has been a critical driver of BrainsWay’s regulatory and quality success in the U.S. and internationally.Ahava has led and supported a wide range of high-impact regulatory initiatives, including securing 11 FDA 510(k) clearances , managing seven clinical studies, and overseeing two real-world data (RWD) collection studies. She has also guided numerous IDE and pre-submission activities, consistently demonstrating strong regulatory judgment, disciplined execution, and an exceptional ability to work effectively with cross-functional teams and external stakeholders. On the international side, Ahava played a central role in obtaining BrainsWay’s original CE Certification in 2008, a foundational achievement that supported our global expansion and compliance posture. Ahava combines deep regulatory expertise with strategic thinking and operational excellence. She is highly dependable, detail-oriented, and relentlessly focused on patient safety and compliance, while also understanding how to move programs forward and achieve business-critical milestones.As CEO of BrainsWay, I can state unequivocally that Ahava has been one of the most effective QA/RA and clinical leaders I have worked with.
AEYE Health worked closely with Ahava Stein as our CRO and regulatory consultant on numerous clinical trials and so far achieving two FDA clearances. Throughout this process, Ahava brought deep regulatory knowledge, strategic thinking, and a hands-on approach that was critical to our success. Her ability to creatively solve complex challenges while maintaining the highest standards of quality and compliance made a meaningful impact on our programs.
Beyond her technical expertise, Ahava’s dedication, reliability, and integrity truly stand out. She is someone you can always trust to take full ownership and deliver. In addition, she has built an excellent team that shares her professionalism and commitment. We cannot appreciate her work enough and highly recommend her to any organization seeking an outstanding CRO and regulatory partner.
I would like to express my strong appreciation and confidence in Ahava Stein for her ongoing work as our Chief Regulatory Officer. Ahava is currently representing our company in front of the FDA with a high level of professionalism, clarity, and credibility. She demonstrates a deep understanding of regulatory requirements and applies a thoughtful, strategic approach in all interactions with the FDA, ensuring that our communications and submissions are clear, accurate, and aligned with regulatory expectations.In parallel, Ahava is actively managing our clinical trial with great rigor and attention to detail. She provides strong oversight of the clinical activities, maintains a high standard of compliance, and coordinates effectively with internal teams and external partners. Her structured and methodical approach contributes significantly to keeping the trial well-organized and properly managed.Ahava brings expertise, reliability, and a strong sense of responsibility to her role. She represents our company with integrity and professionalism and is a trusted leader in both our regulatory and clinical efforts.
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