The Zewski Report is provided for educational and planning purposes only.

It is intended to help early-stage medical device innovators better understand possible development considerations, including cost and timeline ranges, regulatory pathway assumptions, testing needs, prototyping considerations, manufacturing assumptions, and project risks.

The Zewski Report does not provide legal, regulatory, clinical, engineering, investment, or professional advice. Nothing on our site, in the questionnaire, in the report, or in related communications should be relied upon as a substitute for licensed professional services.

Zewski does not guarantee outcomes, including regulatory clearance or approval, funding success, clinical performance, technical feasibility, manufacturing readiness, or commercial results.

You remain responsible for all final decisions, filings, testing, validation, verification, regulatory submissions, design decisions, business decisions, and professional engagements.

Our goal is to provide a structured planning foundation so that, when you engage appropriate specialists, you are better prepared for those conversations.

The Zewski Report may request information about your device concept in order to generate a personalized planning report.

Do not submit confidential, proprietary, trade secret, or unpublished information unless you are comfortable doing so without a non-disclosure agreement.

At this beta stage, use of The Zewski Report does not create a confidential advisory relationship, engineering engagement, regulatory engagement, legal relationship, or client relationship with Zewski.

If your concept has not been publicly disclosed, patented, or otherwise protected, you should consult an intellectual property attorney before sharing sensitive details.

Zewski works with a range of innovators and device concepts. We cannot assume overlapping confidentiality obligations through the standard report questionnaire or beta report experience.

The Zewski Report is intended for early-stage medical device concepts where planning-level development, regulatory, testing, cost, timeline, and manufacturing assumptions may be useful.

The report may not be suitable for every product type or risk profile. Concepts outside our current scope may receive limited, generalized, or less useful outputs.

The Zewski Report is not currently intended for:

• Implantable devices
• FDA Class III devices
• Life-sustaining or life-supporting devices
• Software-only products
• Biological or pharmaceutical products
• Drug-device combination products
• Products requiring specialized clinical, biological, pharmaceutical, or high-risk regulatory expertise

If your concept falls into one of these categories, you should seek specialized professional guidance before relying on any planning-level report.

Any cost ranges, timeline ranges, phase allocations, testing considerations, manufacturing assumptions, regulatory pathway assumptions, or readiness factors included in The Zewski Report are directional planning estimates.

They are based on questionnaire responses, available inputs, general development patterns, and planning assumptions. They are not quotes, commitments, professional determinations, or guarantees.

Actual development cost, timeline, testing requirements, regulatory pathway, manufacturing needs, and project risk may change significantly as the concept matures, requirements are clarified, suppliers are selected, experts are engaged, and evidence is generated.

You are responsible for determining whether The Zewski Report is appropriate for your use.

You are also responsible for engaging qualified professionals when needed, including attorneys, regulatory consultants, clinical advisors, engineers, quality specialists, testing laboratories, manufacturers, investors, or other advisors.

You remain responsible for all product decisions, design outputs, verification and validation activities, risk management, regulatory submissions, intellectual property decisions, funding decisions, and business outcomes.

The Zewski Report is currently available free during beta in exchange for an email address and feedback.

During beta, report content, formatting, available features, access methods, and pricing may change. Free beta access does not guarantee future free access, continued availability, or access to future paid features.

Feedback submitted during beta may be used by Zewski to improve the report experience, clarify outputs, identify errors, evaluate usefulness, and guide future product development.

We may update these terms, report features, access rules, pricing, eligibility criteria, and product notes from time to time.

The current version applies to your use of The Zewski Report at the time you access or generate a report.

If you have questions about whether The Zewski Report is appropriate for your concept, contact Zewski before relying on any report output or planning estimate.