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About

Nick Soro

Nick Soro

Nick Soro (Nicolas Soro) is a hands-on medical device executive with 20+ years shipping FDA-cleared products, holding a Bachelor's in Applied Economics. Founder of Sequence Group, LLC, a medical-device design, development, and quality firm in Fort Lauderdale, FL, along with Limit Outfitter, LLC and Protostar AI, LLC. Previously Chief Operating Officer at Sensus Healthcare (NASDAQ: SRTS), where the business achieved six consecutive record quarters of revenue and growth.

Career

Experience

  1. 2023 - Present

    Founder

    Sequence Group, LLC

    Medical-device design, development, regulatory, and quality consultancy in Fort Lauderdale, FL. Leads product development and FDA submissions for device clients, and is the home of SequenceQMS, a cloud-based eQMS built for medical-device companies.

  2. 2023 - Present

    Founder

    Limit Outfitter, LLC

    Outdoor brand for the modern outdoorsman. Built HuntForge, which automates the Florida FWC permit lottery by monitoring every WMA draw window and auto-submitting applications, alongside an online store for gear.

  3. 2023 - Present

    Founder

    Protostar AI, LLC

    AI software company. Its flagship product is a privacy layer that lets teams use public frontier models on sensitive, regulated data without handing the data over. More at protostarai.com.

  4. 2020 - 2023

    Chief Operating Officer

    Sensus Healthcare (NASDAQ: SRTS)

    Led day-to-day operations across product, regulatory, quality, and commercial functions for a publicly traded medical-device company. The business delivered six consecutive quarters of record revenue and growth.

  5. 2016 - 2020

    Director, Regulatory Affairs & QA

    Sensus Healthcare

    Owned FDA 510(k) submissions, the ISO 13485 quality management system, design controls, risk management, and audit readiness across the superficial-radiotherapy device portfolio.

  6. 2012 - 2016

    Director of RA/QA

    Demetech Corp

    Directed regulatory affairs and quality assurance for a medical-device manufacturer, maintaining FDA and ISO 13485 compliance across the product line.

Research & IP

Publications & patents

Peer-reviewed publication

Inverse treatment planning for an electronic brachytherapy system delivering anisotropic radiation therapy

Physics in Medicine & Biology, Vol. 66, No. 5 (2021)

Co-author. An inverse treatment planning algorithm for the Sculptura electronic brachytherapy system, developed at Sensus Healthcare.

DOI: 10.1088/1361-6560/abda9a

US patent application

Balloon applicator for directional intraoperative and brachy radiation therapy with conformal phantom for 3D anatomical image registration

US20200391052A1, filed 2020 by Sensus Healthcare (application, not granted)

Named inventor, with Kalman Fishman and James Russell Price.

US20200391052A1 on Google Patents

Standards

Certifications & standards

ISO 13485IEC 62304IEC 6060121 CFR 820 / 807 / 11 / 803FDA 510(k)CE Marking