Legal
Terms of Service
These Terms of Service ("Terms") govern your access to and use of the MANKAIND platform and website (the "Service"), provided by MANKAIND ("MANKAIND", "we", "us"). By using the Service, you agree to these Terms. If you are accepting on behalf of a company or other legal entity, you represent that you have the authority to bind that entity.
1. Description of Service
MANKAIND provides an AI-powered software platform that integrates product lifecycle management (PLM) and electronic quality management system (eQMS) capabilities for medical device engineering teams. The platform is designed to help teams generate, organise, and maintain regulatory documentation based on their engineering decisions.
2. Regulatory Disclaimer — Please Read Carefully
MANKAIND is a software tool, not a regulatory consulting service.
The MANKAIND platform, and any documentation, outputs, templates, or suggestions it generates:
- Are not regulatory advice and do not constitute legal, medical, or regulatory consulting of any kind.
- Do not guarantee regulatory approval by the FDA, European notified bodies, or any other regulatory authority.
- Are a starting point that requires review, verification, and approval by qualified personnel at your organisation before any regulatory submission.
Your engineering team remains responsible for all design decisions. MANKAIND documents those decisions — it does not make them. The adequacy of your technical documentation, Design History File, Technical File, or quality management system is determined solely by you and the relevant regulatory authorities.
3. Account Registration
To access the platform, you must create an account with accurate, complete, and current information. You are responsible for maintaining the confidentiality of your account credentials and for all activity that occurs under your account. Notify us immediately at info@mankaind.ai if you suspect unauthorised access.
4. Acceptable Use
You may use the Service only for lawful purposes and in accordance with these Terms. You agree not to:
- Use the Service in connection with the development of any product intended to cause harm to humans.
- Attempt to reverse-engineer, decompile, or extract source code, AI models, or proprietary data from the platform.
- Upload content that infringes the intellectual property rights of any third party.
- Use the Service to transmit malicious code, conduct phishing, or engage in any unlawful activity.
- Misrepresent your identity, your organisation, or the nature of your regulatory submissions.
5. Your Content and Data
You retain ownership of all content, data, and documents you create, upload, or generate using the Service ("Customer Data"), including engineering designs, device specifications, risk analyses, and regulatory documentation.
You grant MANKAIND a limited, non-exclusive licence to process Customer Data solely to provide and improve the Service to you. We will not use your Customer Data to train AI models for third parties or share it beyond what is necessary to operate the platform.
6. Confidentiality
MANKAIND treats your Customer Data as confidential and implements appropriate technical and organisational measures to protect it. You are responsible for ensuring that any Customer Data you upload is appropriate for a cloud-based service and consistent with your own confidentiality obligations, including any obligations to regulators or third parties.
7. Intellectual Property
MANKAIND and its licensors retain all rights, title, and interest in the platform, software, AI models, and underlying technology. These Terms do not transfer any intellectual property rights to you other than the limited right to use the Service as described herein.
8. Payment
Subscription fees, billing periods, and payment terms are set out in the Order Form or subscription agreement between you and MANKAIND. All fees are non-refundable except as expressly stated in that agreement or required by applicable law.
9. Disclaimer of Warranties
THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
MANKAIND DOES NOT WARRANT THAT THE SERVICE WILL BE ERROR-FREE OR UNINTERRUPTED, OR THAT OUTPUTS, TEMPLATES, OR GENERATED DOCUMENTATION WILL BE ACCURATE, COMPLETE, OR SUITABLE FOR SUBMISSION TO ANY REGULATORY AUTHORITY. ALL GENERATED DOCUMENTATION REQUIRES HUMAN REVIEW AND VALIDATION BY QUALIFIED PERSONNEL.
10. Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, MANKAIND'S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS OR THE SERVICE SHALL NOT EXCEED THE TOTAL FEES PAID BY YOU IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM.
IN NO EVENT WILL MANKAIND BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES, INCLUDING LOSS OF REVENUE OR PROFITS, REGULATORY FINES, COSTS ASSOCIATED WITH A FAILED OR DELAYED REGULATORY SUBMISSION, OR HARM ARISING FROM RELIANCE ON PLATFORM OUTPUTS, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
11. Indemnification
You agree to indemnify, defend, and hold harmless MANKAIND and its officers, directors, employees, and agents from and against any claims, damages, losses, and expenses (including reasonable legal fees) arising from: (a) your use of the Service in violation of these Terms; (b) Customer Data you submit to the Service; or (c) your regulatory submissions or filings with any authority.
12. Termination
Either party may terminate the agreement in accordance with the notice period set out in the applicable Order Form. MANKAIND may suspend or terminate your access immediately and without notice if you violate these Terms or if continued access would expose MANKAIND or other users to legal or security risk.
Upon termination, your Customer Data will remain available for export for 30 days, after which it will be deleted from our systems, subject to legal retention obligations.
13. Governing Law
The governing law depends on where you are located:
- European Union / EEA: these Terms are governed by the laws of Spain, without regard to conflict of law principles. Disputes that cannot be resolved amicably will be subject to the exclusive jurisdiction of the courts of Spain.
- United States: these Terms are governed by the laws of the State of Delaware, without regard to conflict of law principles. Disputes will be resolved by binding arbitration under the rules of the American Arbitration Association, except where prohibited by law.
- Rest of world: these Terms are governed by the laws of Spain, and disputes will be subject to the exclusive jurisdiction of the courts of Spain.
Nothing in this section limits either party's right to seek injunctive or other equitable relief in any court of competent jurisdiction.
14. Changes to These Terms
We may update these Terms from time to time. For material changes, we will provide at least 30 days' notice by email or through the platform. Your continued use of the Service after the effective date of updated Terms constitutes acceptance of those changes.
15. General
- Entire agreement: these Terms, together with any Order Form, constitute the entire agreement between you and MANKAIND regarding the Service.
- Severability: if any provision is found unenforceable, the remaining provisions continue in full force.
- No waiver: failure to enforce any provision does not constitute a waiver of our rights.