All Zewski Report offerings are provided for educational and strategic planning purposes only.

• We do not provide legal, regulatory, clinical, or investment advice or representation. Nothing in our site, reports, plans, or conversations should be relied upon as a substitute for licensed professional services in those domains.
• Zewski does not guarantee outcomes, including regulatory clearance or approval, funding success, clinical performance, or commercial results.
• You remain fully responsible for all final decisions, filings, testing, validations, regulatory submissions, and business outcomes.

Important: Our goal is to equip you with clarity and structure so that, when you do engage specialized experts (regulatory consultants, attorneys, clinical advisors, or investors), you are prepared with a well-informed foundation.

Zewski works with a wide range of innovators and cannot assume overlapping confidentiality obligations at the report or short-term advisory stage.

Library Reports are pre-built assessments of existing device types and do not involve client-supplied confidential information.

Custom Reports are provided without non-disclosure agreements (NDAs). Clients must secure their own intellectual property protections, such as a published application or granted patent, before requesting a Custom Report. Projects that are already publicly disclosed (e.g., through a university or open-source release) may also be eligible.

Guided Reports are long-term advisory engagements. For these projects, an NDA is included to ensure mutual confidentiality and to support innovators working with provisional or unpublished filings.

The Zewski Report services are not suitable for the following device categories, which are beyond our scope of expertise:

•  Implantable devices
•  FDA Class III devices
•  Software-only devices
•  Biological or pharmaceutical products
•  Life-sustaining or life-supporting devices

Library Reports are general reference tools designed to give inventors early insight into the development journey. They are not customized to your specific device or regulatory path. Any testing matrices or timelines included are illustrative only. Reports are educational and exploratory, and do not create an engagement or guarantee of outcomes.

Custom Reports are planning frameworks for devices with a granted or pending patent. They provide structured timelines, budgets, and risk maps to help you chart a path forward. All figures are estimates and may shift with project scope, evidence, or third-party requirements. Custom Reports do not guarantee FDA clearance/approval or market success.

Guided Reports bundle a Custom Zewski Report with structured consultation and strategic guidance during the pre–design and development phase. Engagements are limited in scope and typically span 12–18 months. These services are not a substitute for engineering execution, regulatory representation, or legal counsel.

The time and deliverables available under Guided Reports are defined in your agreement. Hours are allocated on a “use it or lose it” basis each period and do not carry over. Any activities outside the documented scope require a separate engagement.

Any cost/time calculators, phase allocations, or testing matrices are directional models. They depend on project data, supplier quotes, and evolving requirements. Results are not commitments and may change as information matures.

You are responsible for design decisions, validations, verifications, risk management, and regulatory submissions. Where third-party experts (e.g., legal, regulatory, clinical) are required, you are responsible for engaging them and for their outputs.

We may update these terms and product notes from time to time. The current version applies to your use of Zewski Report offerings. For questions, contact us before relying on any estimate or plan.

Investments in Custom Reports or Guided Reports may be applied as a credit toward future Zewski design & development engagements. Credits are non-refundable, non-transferable, and must be used within 12 months of purchase. Zewski determines credit amounts and eligibility at the time of engagement.