Sebastian is Accurate Consultants Program Manager who plans and oversees design and development of multiple medical devices to market. Activities include regulatory strategy, planning, pre-production, production and post-market. Sebastian is also an acting Quality Manager to align all processes with 21 CFR 820 QSR’s and ISO 13485:2016 (QSMR).
He has developed Quality Management Systems for multiple firms in both hard copy and eQMS versions, implemented all major subsystems and ran Design Control and Risk Management implementation across multiple medical devices. Manages and assists clients to resolve various FDA Regulatory and Compliance issues, includes FDA 483 response and Warning Letter remediation projects to close-out. Also manage Device and Drug FDA Registration and Listings, handling Import and Export Compliance and remediation of Product hold issues.
He has successfully submitted many Medical Device Regulatory Filings including 513(g), Pre-Submissions, 510(k)’s, Pre-EUAs, and EUA’s.

510(k) Submissions submitted and cleared by FDA include:
o K250821 – 2025 – Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)
o K242503 – 2025 – Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
o K211209 – 2021 – Hycare International Nitrile and Latex Patient Examination Gloves
o K200977 – 2020 – Operating Room Innovations Inc. Modular Toga Submission