Legal

Last updated: March 2026

Disclaimer

BioEvalPro is a documentation evaluation tool. It evaluates the structure, completeness, and internal consistency of biological evaluation documentation against published regulatory standards and guidance. It does not provide regulatory advice, legal counsel, or scientific determinations.

All findings and recommendations from BioEvalPro should be reviewed and approved by qualified regulatory and scientific professionals before any action is taken. Product safety determinations and notified body or FDA approval outcomes are the sole responsibility of the submitting organization.

BioEvalPro does not guarantee regulatory approval, certification, or clearance of any medical device. The tool is intended to support, not replace, the judgment of qualified professionals involved in the biological evaluation process.

Privacy Policy

BioEvalPro collects personal information that you voluntarily provide when you join our waitlist, submit a contact form, or use the platform. This includes your name, email address, company name, and any messages you send through our contact form.

When you use the BioEvalPro platform, your uploaded documents are stored securely and are accessible only to you through your account. We do not share, sell, or distribute your uploaded documents or evaluation reports to any third party.

We use your contact information to communicate with you about your account, product updates, and early access availability. We do not sell your personal information. We do not send unsolicited marketing emails beyond the communications you have opted into.

Data storage and security. All data is encrypted in transit and at rest. Documents and reports are stored in a secure portal accessible only through your authenticated account. We use industry-standard security practices to protect your information.

GDPR. If you are located in the European Economic Area, you have rights under the General Data Protection Regulation including the right to access, correct, or delete your personal data. A Data Processing Agreement (DPA) is available on request. To exercise any of these rights, contact us at [email protected].

Cookies. This website does not use tracking cookies. We may use essential cookies required for site functionality.

Third-party services. We use third-party services for hosting, form processing, and analytics. These services may process limited personal information (such as your IP address) in accordance with their own privacy policies. We do not share your uploaded documents with any third-party service.

Terms of Use

By using the BioEvalPro website and platform, you agree to the following terms.

Use of the platform. BioEvalPro is provided for the purpose of evaluating biological evaluation documentation quality. You are responsible for the accuracy and completeness of the documents you upload. You retain full ownership of all documents you upload and all reports generated from your submissions.

Intellectual property. All content on this website, including text, graphics, design, and software, is the property of BioEvalPro and is protected by applicable intellectual property laws. You may not reproduce, distribute, or create derivative works from this content without written permission.

Your content. You retain all rights to the documents you upload. By uploading documents, you grant BioEvalPro a limited license to process your documents for the sole purpose of generating your evaluation report. We do not use your documents for any other purpose, including training, marketing, or sharing with other users.

Limitation of liability. BioEvalPro is provided as a documentation evaluation tool only. We are not liable for any regulatory decisions, submission outcomes, or business consequences resulting from the use of our reports. The submitting organization bears full responsibility for the content and accuracy of regulatory submissions.

Availability. We aim to provide reliable access to the platform but do not guarantee uninterrupted availability. We reserve the right to modify, suspend, or discontinue the platform at any time.

Changes to these terms. We may update this page from time to time. The "last updated" date at the top of this page reflects the most recent revision. Continued use of the platform after changes constitutes acceptance of the revised terms.

Contact

For questions about this page, your data, or to request a DPA, contact us at [email protected].