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Guiding Your Medical Device to Market with Regulatory and Technical Expertise
We efficiently guide clients navigating the complex medical device regulatory requirements and strive to expedite time-to-market. Our foundation is 15 years of industry and regulatory (FDA) experience which we will apply towards every stage of your medical device life cycle ranging from design, implementation, evaluation, to regulatory approval/clearance and post-market performance. We harness our FDA institutional knowledge, regulatory expertise, and technical proficiency, to help innovators introduce their medical device technology to market. For more information about our solutions & services, click here.
Let the combination of our regulatory and technical expertise give you an edge.
Who We Are
Bahram Parvinian, founder and principal consultant at Lighthouse Regulatory Consulting Group, served at the Food and Drug Administration (FDA) in the Office of Device Evaluation (ODE) from 2006 to 2019. He started as lead reviewer of surgical implants (2006-2008) and respiratory and anesthesia devices (2008-2011). In 2011, he shifted his dedication and focused primarily on the review of safety-critical life-sustaining/supporting devices in ODE, taking on the most challenging submission types, 510(k) with clinical data, clinical trial applications (IDE), de novos, original premarket approval (PMA) applications; his reviews included closed-loop automated drug-delivery systems. In his capacity as lead reviewer and senior regulatory expert of life-sustaining/life-supporting medical devices, he reviewed and made regulatory recommendations for over 200 510(k) notifications, 20 original IDEs, five original de novo applications, and three original PMA devices, the latter involved advanced automated drug-delivery and combination products. In 2014, he founded the FDA-CDRH physiological closed-loop controlled (automated) devices working group aimed at addressing regulatory and technical challenges facing digital health technologies (e.g., smart algorithms, indices, physiological sensors, infusion pumps) to be ultimately used towards innovative automated critical care systems. As leader of the working group, and FDA subject matter expert, he has published articles, co-authored international consensus standards, and drafted FDA guidance documents related to intelligent sensors, novel monitoring systems, and automated drug-delivery devices, intended to promote innovation in how care is delivered to patients in surgical and critical care settings. Bahram holds a B.S. in biological engineering from University of Maryland College Park and M.S. in biomedical engineering from Johns Hopkins University with a focus in mathematical modeling of physiological systems. He holds a Ph.D. in mechanical engineering with a focus on validation and reliability assessment of mathematical models used for design and evaluation of clinical-decision support and automated critical care medical devices. For a list of regulatory and scientific publications, please click here.
Regulatory Solutions and Services
Regulatory Strategy
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Regulatory designation
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Regulatory classification
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Selection of predicate devices / product codes
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Complete Response Letter Remediation
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Q-sub/Pre-sub strategy
Technical Consulting
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Pre-clinical performance testing and safety evidence generation
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Risk identification, analysis , and mitigation
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Clinical study design and conduct
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Use of real world evidence
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Guidance on implementing device iterations before, during, and after clinical studies
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Review of technical reports to support marketing applications
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Assessment of regulatory risk for investors
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Advising Acquirers
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Preparation for investor pitch
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Start up, incubators, accelerators
Regulatory Due Diligence
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Mock "FDA style" review of Qsub,IDE,510(k),PMA, 513(g), HDE, and RFDs.
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Review of substantial equivalence case
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Review of risk mitigation strategy for IDEs, PMAs, HDEs and De Novo.
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Review of benefit/risk discussion
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Labeling and promotional material review