All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, and Safety Assurance Cases
Consulting Specialties
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Device, Drug, and Biologic Combination Product Development Strategy (delivery platform selection, bridging strategy, threshold analysis), Design Controls (DHF), Risk Management, Cybersecurity and Assurance Cases
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Global Product Risk Management Compliance and Best Practice Training, Assessment and Implementation
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Digital Health, SaMD, Connected Health, and Artificial Intelligence(AI) System Safety, Cybersecurity, and Compliance
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Clinical Risk Assessment/Rationale, Benefit vs Risk Analysis
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Pre-Market Approval/Clearance Issue Resolution and Post-Market Issue Remediation
Senior Consultants
Fubin Wu
Co-founder and President of GessNet™, formerly Quality Director and Manager with Medtronic, Hospira, and Haemonetics.
Fubin has guided the development of 25+ drug delivery device and combination product safety assurance cases that holistically explain to the FDA why these medical products are safe and effective in connecting to the evidence of design control and risk management documentation records. He has also helped over 35 companies improving their design controls/risk management process/practices.
Fubin and his team have recently developed QMSpace software, which provides all in one solution for design controls, risk management, cybersecurity, and safety and compliance assurance cases. The objective of QMSpace is to intuitively guide the user to implement the industry design controls and risk management best practices in developing and maintaining safe, effective and compliant medical products. Previously he designed the TurboAC™ Risk Management and Assurance Case Software working with FDA CDRH OSEL and industry subject matter experts.
Fubin is a member of multiple AAMI standard development working groups including combination products, infusion devices, cybersecurity and software. He also serves as AAMI Instructor for Medical Device Safety Assurance Cases Course, and PDA Instructor for Drug Delivery Device and Combination Product Risk Management and Cybersecurity
Jessica Eisner, MD
Dr. Eisner spent 4 years as a Senior Medical Officer at the US FDA (both CDER and CDRH) where she provided medical leadership, expert scientific review, and science-based regulatory input for selected drug & device issues while meeting Congressionally-mandated deadlines for medical review of INDs, Q-subs, IDE, 510(k)s and “de novo” applications, as well as NDAs, protocols, clinical trial design, adverse event and periodic reporting submissions.
Dr. Eisner was a CDRH General Hospital Device Branch [GHDB] Medical liaison and Senior Medical Consultant to CDER Office of Combination Products Inter-Center Consults as well as and a policy analyst for various cross-Center projects and issues (e.g. FDASIA Health IT Policy Report, and the IMDR Software for Medical Devices Framework for Risk Categorization & Controls). She authored several GHDB Branch policy white papers on safety issues and software systems and worked with Compliance to pursue and halt fraudulent and inappropriate Sponsors. In addition, Dr. Eisner was appointed a core member of the General Hospital Safety Signal Review Team that investigated identified and potential medical device performance issues, recalls, and device-related adverse events.
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Paul Jones
With 24 years’ experience at FDA/CDRH as a senior systems/software engineer and as FDA’s software systems safety engineering expert, Paul jones, has provided software, risk management, and cybersecurity premarket reviews (including 510(k). PMA, De Novo, Q-sub, IDE) for hundreds of devices including general hospital, cardiovascular, surgical, radiological (RTP, LINAC, PROTON), blood establishment, combination devices, and many other types. He has carried out inspections, investigations, and training for the FDA Office of Regulatory Affairs. He has also provided training to FDA staff on software quality, risk management, software engineering, and model-based engineering. He was also a member of the Digital Health Committee.