At The Zewski Report, we offer strategic advisory services to help innovators navigate product development, regulatory pathways, and industry connections. However, our services do not include formal engineering work, legal guidance, or regulatory submissions. All recommendations are for planning purposes only and should not be considered a guarantee of market success, FDA approval, or product viability.

Intellectual Property & NDA Policy:
We work with hundreds of innovators and, as such, do not sign NDAs for initial consultations, reports, or short-term advisory services. Clients are responsible for securing their own intellectual property protections, such as a provisional or granted patent, before sharing details. If you engage with us in a long-term agreement, we are happy to sign an NDA to ensure mutual confidentiality.

Service Terms:

• Class I & II Exempt Plans: Provides a structured development plan for low-risk medical devices that do not require FDA 510(k) clearance. Includes cost estimates, timelines, and regulatory classification guidance. Does not include formal engineering work or guarantee market success.
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• Class II 510(k): Designed for devices requiring FDA 510(k) submission, outlining costs, design controls, and compliance pathways. Includes regulatory strategy and verification testing planning. Does not include engineering services or guarantee FDA clearance.
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• Class III or DeNovo: Supports high-risk medical device development with a structured roadmap for regulatory approval, including risk mitigation and clinical validation planning. Does not include engineering work, legal advice, or guarantee FDA approval
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• IMPORTANT: All program plans are provided in Excel format with Gantt charts in PDF format. Online access requires a 12-month Investor or Advisor service. These plans offer strategic guidance but do not include formal engineering work, legal advice, or guarantee regulatory approval or market success.
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Before purchasing any service, we strongly recommend scheduling a consultation to ensure alignment with your development needs. Purchases made without prior discussion may be subject to delays or adjustments.

By proceeding with our services, you acknowledge and accept these terms.

🔹 This plan provides a structured outline for developing low-risk medical devices that do not require a 510(k) submission. It includes a detailed cost estimate, task breakdown, and timeline for concept development, risk assessment, regulatory classification, basic verification testing, and manufacturing readiness. A Gantt chart maps out key milestones to streamline execution and market entry. This plan also includes a 1-hour pre-planning call, a 1-hour post-planning call, and one round of revisions to ensure alignment with your needs.🚨

🔹 Designed for medical devices requiring FDA clearance, this plan includes a comprehensive cost and task breakdown covering design control, risk management, verification and validation testing, and regulatory documentation preparation. A structured Gantt timeline ensures an efficient 510(k) submission process, reducing delays and unforeseen costs. This plan also includes a 1-hour pre-planning call, a 1-hour post-planning call, and one round of revisions to refine and tailor the strategy to your specific device.🚨

🔹For complex, high-risk medical devices requiring a PMA or De Novo submission, this plan outlines extensive engineering, preclinical and clinical testing, and full regulatory approval pathways. It includes a detailed cost analysis, phased task structure, and a Gantt chart covering feasibility studies, risk mitigation, validation trials, and final FDA submission to ensure a clear, structured path to approval. This plan also includes a 1-hour pre-planning call, a 1-hour post-planning call, and one round of revisions to optimize the approach based on your development goals.🚨