Terms of Service

Last updated: 07/27/2026

These Terms and Conditions ("Terms") govern your access to and use of the website located at [omomedical.com] and any subdomains, pages, tools, or content made available through it (collectively, the "Site"), including the Regulatory Readiness Assessment (the "Assessment").

The Site is operated by CreateDevs LLC, doing business as "OMO Medical" ("OMO Medical," "we," "us," or "our").

By accessing or using the Site, you agree to be bound by these Terms. If you do not agree, do not use the Site.

The Site is intended for business use by professionals evaluating medical device, Software as a Medical Device (SaMD), or digital health product development and regulatory strategy. You must be at least 18 years old and have the authority to enter into these Terms on behalf of yourself or the organization you represent.

The Site is not intended for use by patients or consumers seeking medical care.

This is the most important section of these Terms. Please read it carefully.

All content on the Site, including the Assessment, readiness scores, suggested FDA pathways, identified gaps, articles, and any other output, is provided for general informational and educational purposes only.

Specifically, you acknowledge and agree that:

• Nothing on the Site is regulatory advice. Output from the Assessment is a directional, automated estimate based solely on the limited answers you provide. It is not a regulatory determination, classification decision, pathway confirmation, or submission strategy.
• Nothing on the Site is legal advice. No attorney-client relationship is created by using the Site or contacting us through it.
• Nothing on the Site is medical advice. The Site does not diagnose, treat, or provide guidance on the care of any individual patient.
• We are not the FDA or any regulatory authority. Only the U.S. Food and Drug Administration and other applicable regulatory bodies can determine device classification, regulatory pathway, or clearance and approval outcomes.
• No outcome is guaranteed. Use of the Site or engagement of our services does not guarantee FDA clearance, approval, certification, audit success, or any particular regulatory or commercial result.

You should not act, or refrain from acting, on the basis of anything on the Site without obtaining independent professional advice from qualified regulatory, legal, quality, and clinical advisors regarding your specific product and circumstances.

The Assessment is a free, automated tool that generates a directional output based on a small number of self-reported inputs.

You acknowledge that:

• The output depends entirely on the accuracy and completeness of the information you provide.
• The Assessment does not review your product, source code, documentation, quality system, clinical data, or intended use statement.
• Regulatory frameworks change. Output may not reflect the current guidance, rules, or precedent.
• The Assessment may use automated processing, including AI or machine learning systems, to generate output. Automated output may contain errors, omissions, or inaccuracies, and must be independently verified.
• Assessment results are provided "as is," with no representation as to accuracy, completeness, or fitness for any purpose.

Do not submit confidential, proprietary, trade secret, protected health information (PHI), or regulated data through the Assessment or any form on the Site. The Site is a marketing and informational tool and is not designed or intended to receive such information. See our Privacy Policy.

The Site describes services we may offer, including SaMD development, product development, concept and validation work, QMS and ISO 13485 support, and coordination of regulatory documentation and submissions.

Nothing on the Site constitutes an offer to provide services, and no engagement exists until a separate written agreement, such as a master services agreement, statement of work, or consulting agreement, is signed by both parties. In the event of a conflict between these Terms and a signed services agreement, the signed services agreement controls those services.

Certain regulatory strategy, quality management system, and submission activities are performed by or in coordination with independent third-party consultants and partners, including Brooke & Associates. Those parties are responsible for their own work product, professional judgment, and compliance obligations.

All content on the Site, including text, graphics, logos, icons, illustrations, the OMO Medical name and marks, the Assessment methodology, scoring logic, interface designs, and underlying software, is owned by OMO Medical or its licensors and is protected by copyright, trademark, and other intellectual property laws.

You may view and print Site content for your own internal, non-commercial evaluation purposes. You may not:

• Copy, reproduce, republish, distribute, or publicly display Site content except as permitted above;
• Modify, adapt, translate, reverse engineer, decompile, or create derivative works from the Site or the Assessment;
• Scrape, crawl, harvest, or use automated means to extract data from the Site without our prior written consent;
• Use the Site or its output to build, train, or improve a competing product, dataset, or model;
• Remove or obscure any proprietary notices.

Third-party names, logos, and marks appearing on the Site are the property of their respective owners.

If you submit information through a contact form, consultation request, or the Assessment (including your name, work email, company name, role, and message), you represent that:

• The information is accurate and you are authorized to provide it;
• You are not submitting protected health information, personal data of third parties, or another party's confidential information;
• Your submission does not infringe any third party's rights or violate any law or agreement.

You grant us a non-exclusive, worldwide, royalty-free license to use submitted information for the purpose of responding to you, providing the Assessment, and improving the Site and our services, in accordance with our Privacy Policy. Unsolicited submissions are not treated as confidential unless covered by a signed confidentiality agreement.

You agree not to:

• Use the Site for any unlawful purpose or in violation of any applicable law or regulation;
• Attempt to gain unauthorized access to the Site, its servers, or related systems;
• Interfere with, disrupt, overload, or attempt to disable the Site;
• Introduce malware, viruses, or any harmful code;
• Impersonate any person or entity, or misrepresent your affiliation;
• Use the Site to transmit unsolicited commercial communications.

We may suspend or terminate your access to the Site at any time, without notice, for any reason, including suspected violation of these Terms.

The Site may link to or rely on third-party websites, tools, hosting providers, and analytics services. We do not control and are not responsible for the content, accuracy, availability, security, or practices of any third party. Links do not imply endorsement. Your use of third-party services is governed by their own terms and privacy policies.

THE SITE AND ALL CONTENT, INCLUDING THE ASSESSMENT AND ITS OUTPUT, ARE PROVIDED "AS IS" AND "AS AVAILABLE," WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, OR STATUTORY.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE DISCLAIM ALL WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, AND ANY WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

WE DO NOT WARRANT THAT THE SITE WILL BE UNINTERRUPTED, SECURE, OR ERROR-FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT ANY CONTENT OR ASSESSMENT OUTPUT IS ACCURATE, COMPLETE, CURRENT, OR RELIABLE.

Some jurisdictions do not allow the exclusion of certain warranties, so some of the above may not apply to you.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, OMO MEDICAL AND ITS OFFICERS, DIRECTORS, EMPLOYEES, CONTRACTORS, AGENTS, PARTNERS, AND LICENSORS WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE DAMAGES, OR FOR ANY LOSS OF PROFITS, REVENUE, DATA, GOODWILL, BUSINESS OPPORTUNITY, REGULATORY CLEARANCE, TIME TO MARKET, OR ANTICIPATED SAVINGS, ARISING OUT OF OR RELATING TO YOUR USE OF OR INABILITY TO USE THE SITE OR THE ASSESSMENT, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE, AND WHETHER OR NOT WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

OUR TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATING TO THE SITE WILL NOT EXCEED [ONE HUNDRED U.S. DOLLARS ($100)].

This limitation does not apply to liability that cannot be excluded or limited under applicable law.

You agree to indemnify, defend, and hold harmless OMO Medical and its officers, directors, employees, contractors, agents, and partners from and against any claims, liabilities, damages, losses, and expenses (including reasonable legal fees) arising out of or related to: (a) your use of the Site; (b) your violation of these Terms; (c) your violation of any law or third-party right; or (d) any decision you make or action you take in reliance on Site content or Assessment output.

We may modify, suspend, or discontinue any part of the Site at any time without notice.

We may revise these Terms at any time. The "Last updated" date above indicates when changes took effect. Material changes will be posted on this page. Your continued use of the Site after changes are posted constitutes acceptance of the revised Terms.

These Terms are governed by the laws of [STATE / JURISDICTION], without regard to conflict of law principles. You agree that any dispute arising out of or relating to these Terms or the Site will be resolved exclusively in the state or federal courts located in [COUNTY, STATE / JURISDICTION], and you consent to personal jurisdiction and venue there.

• Severability. If any provision of these Terms is held unenforceable, the remaining provisions remain in full force.
• No waiver. Our failure to enforce any provision is not a waiver of our right to do so later.
• Assignment. You may not assign these Terms without our written consent. We may assign them freely.
• Entire agreement. These Terms, together with the Privacy Policy, constitute the entire agreement between you and us regarding the Site, and supersede any prior understandings regarding the Site.

Questions, requests, or complaints about this Policy or our data practices:

OMO Medical | CreateDevs LLC | 1078 Summit Ave, Jersey City, NJ 07307 Email: office@createdevs.com