Consulting Specialties
- 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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- Regulatory and Clinical Strategy Development and Regulatory Submissions
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- Digital Health, SaMD, Connected Health, and Artificial Intelligence(AI) System Safety, Cybersecurity, and Compliance
- Global Product Risk Management Compliance and Best Practice Training, Assessment and Implementation
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- System engineering (system architecture design, requirements management, verification and validation testing management)
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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
Consultants
Fubin wu
Co-founder and President of GessNet™, formerly Quality Director and Manager with Medtronic, Hospira, and Haemonetics.
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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.
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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
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Paul jones
Mercedes Massana
justin shimidt
Richard wu
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.
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.
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Mercedes Massana is the founder and CEO of her own consulting firm, which provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. With over thirty-five years in the medical device sector, Mercedes has contributed to the development of more than 30 marketed medical devices, including pacemakers, dialysis machines, infusion pumps, surgical robots, blood analyzers, dental implants, and autoinjectors, among others. She is an INCOSE-certified Expert Systems Engineer Professional and an ASQ-certified Biomedical Auditor, Software Quality Engineer, Quality Manager, Quality Auditor and Reliability Engineer. Mercedes is also RAPS Devices Certified and has served as an expert witness in the areas of Software Development and Risk Management.
As an expert systems engineer, Mercedes possesses extensive experience with various modern requirement management/PLM software systems and has played a crucial role in guiding the design of QMSpace software to address the common limitations of existing solutions. She is passionate about consulting and supporting the implementation of QMSpace software.
Justin is a Systems Engineering leader with experience developing a broad range of medical devices and combination products with a focus on drug delivery. Justin provides expertise in Product Development, Requirements Development/Management, and Risk Management. Justin has led the development and integration of quality system procedures, ensuring the implementation of state-of-the-art processes. Justin is well versed in the requirements of FDA QSR, EU MDR, ISO 13485, ISO 14971, IEC 62366, IEC 60601, ISO 11608 ISO 11040. He has effectively managed development teams across multiple time zones, executing strategies to improve communication and meet organizational goals and timelines.
As an expert systems engineer, Justin has rich experience with various modern requirement management/system engineering software tools, and has been instrumental in providing input and feedback during the design of QMSpace software. He is excited about consulting and supporting the implementation of QMSpace software.
Richard is a seasoned Systems Engineer with over eight years of specialized experience in the development of infusion pumps. He has deep technical expertise in Product Development, Requirements Development/Management, and Risk Management and has led teams through successful 510(k) submissions. He holds a Black Belt in Design for Six Sigma and has been granted five patents by the USPTO, with an additional seven patents pending. As an expert systems engineer, Richard has been instrumental in providing input and feedback during the design of QMSpace software. He is excited about consulting and supporting the implementation of QMSpace software.