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Guiding Your Medical Device to Market with Regulatory and Technical Expertise
Bahram Parvinian, PhD Principal Consultant
Bahram is the founder and Principal Consultant at Lighthouse Regulatory Consulting Group. Lighthouse has been guiding manufacturers of medical devices towards generating in silico evidence for medical device clinical trial initiation and marketing approvals. Prior to founding Lighthouse, Bahram served at FDA-CDRH from 2007 to 2019 as senior lead reviewer and team leader of critical care and autonomous drug delivery devices (510(k), PMA, De Novo, 513(g), IDE, IND). In his role at FDA, he authored numerous publications related to silico evidence in physiological models, co-authored international consensus standards, and drafted FDA guidance document on physiological closed-loop controlled medical systems. Bahram holds a BS in biological engineering from University of Maryland College Park, MS in biomedical engineering from Johns Hopkins University, and a Ph.D. in mechanical engineering from University of Maryland College Park. His graduate research focused on credibility assessment of mathematical physiological models used for design and evaluation of clinical-decision support and automated medical devices.
Sousan Altaie, PhD, Senior Regulatory Consultant
Dr. Altaie has a well-documented ability to establish and lead a variety of regulatory teams in the development of medical devices especially in vitro diagnostics and antimicrobial drugs. Proven track record of maintaining excellent working relationships within the U.S. FDA and international regulatory agencies such as Health Canada, Australia’s Therapeutic Goods Administration, Japan’s Pharmaceuticals and Medical Devices Agency, European Medicines Agency, China Food and Drug Administration. Expert in planning and execution of the regulatory pathways for HDE, 510(k)s, IDEs, PMAs, INDs, NDAs, ANDAs, and other regulatory submissions toward comprehensive review of safety and effectiveness of medical products. Extensive experience working within FDA’s CDRH, OIR, ODE, CDER, and with other Centers and Offices of the FDA in reviewing various types of devices including combination products, companion diagnostic products, applications for Clinical Laboratory Improvement Amendments (CLIA) waivers as well as antimicrobial drug products.Strong working knowledge of FDA’s QSR requirement for In vitro diagnostics as well as involvement in development and implementation of review policy for all premarket applications, guidance documents, 513(g)s and classification/reclassification actions.
Golnaz Moeini, Senior Regulatory Consultant
Golnaz 'Naz' provides medical device and digital health regulatory strategy and quality consulting services. Prior to being a consultant, Naz was a Director of Quality and Regulatory at Arterys, a medical imaging startup based in San Francisco. Under her leadership, Arterys received FDA clearance for the first-ever cloud-based machine learning imaging 510(k) application in 2017. Naz is passionate about facilitating the regulatory approval of novel medical technologies and has over 18 years of industry experience. She has been involved with several working groups defining the regulatory standards for machine-learning medical device products. She has helped author a whitepaper entitled Perspective and Good Practices for AI and Continuous Learning Systems in Healthcare, published on August 24, 2018. She has also taught digital health regulatory science modules at Stanford Byers Center for Biodesign and is one of the TMCi advisors. She works on a broad spectrum of digital health and biotech devices, including Software as a Medical Device (SAMD), Software as Service (SAS), Drug Discovery, Decision Support Software, Diagnostic devices, Wearable Devices, Cloud, Deep Learning, Machine Learning, AI, Medical Imaging Devices, Computer Assisted Detection and Diagnostic Software, Therapeutic Device, Mobile Medical apps, Telemedicine, and General Wellness regulatory submissions.
Leo Volakis, PhD, Scientific Consultant
Dr. Volakis has a multidisciplinary background, encompassing engineering, medicine, physiology, cellular biology, clinical & life sciences, statistics, and computer science, stemming from his interest in medical research and passion to advance medical technology to benefit public health. During his undergraduate (B.S.) at the University of Michigan and graduate studies (M.S., PhD) at The Ohio State University, he developed, participated in, and completed various multidisciplinary research projects in a wide range of topics related to medical science/technology, imaging modalities, diagnostic tools for diseases (chronic & acute), cellular/molecular/tissue engineering, and microdevices. He has an undergraduate degree in Mechanical Engineering, and dual-graduate degrees in Biomedical Engineering. Outside of his research background, he has academic teaching experience during biomedical graduate studies, and mentorship/training of over 10 individuals within Industry.Beyond his scientific contributions, Dr. Volakis developed two industry research programs establishing infrastructure to enable large-scale quality data generation. From clinical trial design to advanced statistical modeling, his technical acumen fuels data-informed decision making, while his passion for mentoring future generations has guided over 10 rising leaders.