Welcome to Empowerreg’s Terms of Service (these “Terms”). These Terms govern your access to and use of the Empowerreg website, including https://Empowerreg.ai, and all related software, applications, portals, dashboards, integrations, artificial intelligence-enabled features, data tools, analytics, reports, documentation, support, and related services that we make available (collectively, the “Services”).
These Terms constitute a legally binding agreement between you and Empowerreg Corp., a Delaware corporation (“Empowerreg,” “we,” “our,” or “us”). These Terms apply to the individual or entity accessing or using the Services (“Customer”). If you access or use the Services on behalf of a company or other legal entity, you represent and warrant that you have authority to bind that entity to these Terms. In that event, “Customer,” “you,” and “your” refer to that entity.
By accessing or using the Services, you agree to these Terms and the Empowerreg Privacy Policy, available at [link]. If you do not agree, you may not access or use the Services.
We may modify these Terms from time to time. If we do, we will post the updated Terms on the Services or provide notice by other reasonable means. Your continued use of the Services after the updated Terms become effective constitutes your acceptance of them.
We may change, modify, suspend, discontinue, or remove all or part of the Services at any time. Certain Services may be offered in alpha, beta, preview, pilot, evaluation, early-access, or pre-release form. These features may contain errors, interruptions, bugs, or incomplete functionality and are provided on an “AS IS” basis.
Empowerreg provides a technology platform for medical-device, in-vitro-diagnostic, and other regulatory and quality professionals. The Services may include complaint intake and management, post-market-surveillance workflows, vigilance and reportability-support tools, product and market data management, risk analysis, signal detection, data visualization, reporting, regulatory-information integrations, workflow automation, artificial intelligence-enabled functionality, and related services. The Services are designed to support Customer’s regulatory, quality, product, and post-market activities. They do not replace Customer’s quality management system, risk management processes, internal controls, professional judgment, or responsibility for regulatory and compliance decisions.
Customer remains solely responsible for, among other things: (a) determining whether and how to investigate, classify, assess, escalate, document, report, or close complaints, adverse events, vigilance matters, or other quality events; (b) determining whether a report, submission, corrective action, or other action is required; (c) reviewing and validating all data, analyses, recommendations, reports, and other outputs generated through the Services; (d) maintaining appropriate records and procedures; and (e) complying with applicable laws, regulations, standards, and requirements of regulators, notified bodies, customers, and other third parties.
The Services, including any artificial intelligence-enabled outputs, are provided for informational and operational-support purposes only. They do not constitute legal, medical, regulatory, clinical, quality-system, accounting, or other professional advice, and Empowerreg does not guarantee that use of the Services will satisfy any legal, regulatory, quality-system, reporting, audit, certification, validation, or market-access requirement. Customer should consult its own qualified advisers and make its own independent determinations.
Certain Services may interoperate with third-party data sources, regulatory databases, software platforms, or other third-party services. Empowerreg does not guarantee the accuracy, completeness, availability, timeliness, or continued accessibility of any third-party data or services.
From time to time, Empowerreg may make available pre-release, beta, pilot, evaluation, early-access, or experimental features, products, services, integrations, functionality, or content (collectively, “Beta Features”). Participation in any beta program, pilot, evaluation, waitlist, or similar initiative is at Empowerreg’s discretion, and Empowerreg may approve, deny, suspend, revoke, or discontinue participation at any time. Beta Features may be incomplete, contain errors, experience interruptions, produce inaccurate or incomplete results, change materially, or be discontinued without notice. Beta Features are provided for evaluation and testing purposes and may not be subject to the same support, availability, security, performance, or reliability standards as generally available Services.
Empowerreg makes no commitment regarding the future availability, functionality, pricing, or commercial release of any Beta Feature. Customer’s use of Beta Features is voluntary and at Customer’s own risk. Empowerreg may impose additional terms, restrictions, or eligibility requirements for particular Beta Features. Any product descriptions, development plans, roadmaps, timelines, anticipated releases, future functionality, integrations, or planned features are informational only and do not create any obligation to deliver a particular feature, integration, product, service, or release date.
Customer may be required to create and maintain an active account to use certain portions of the Services (an “Account”). Customer may allow its employees, contractors, consultants, and other authorized personnel (“Authorized Users”) to access the Services through Customer’s Account, subject to these Terms. Customer is responsible for all acts and omissions of its Authorized Users. Account registration may require Customer to provide information such as Customer’s name, company name, email address, phone number, billing information, and other account-related information (“Account Information”). Customer will provide accurate, current, and complete Account Information and keep it current. Customer is responsible for maintaining the confidentiality and security of its Account credentials and for all activity occurring through its Account. Customer will promptly notify Empowerreg of any unauthorized use of its Account or other suspected security incident involving the Services.
Certain Services may be offered on a subscription, pilot, project, implementation, consulting, custom-engagement, or other paid basis. Customer will pay all fees associated with its use of the Services as set forth in the applicable order form, proposal, statement of work, invoice, subscription plan, or other written agreement between Customer and Empowerreg. Unless otherwise agreed in writing, fees are stated and payable in U.S. dollars and are non-refundable. Invoices are due in accordance with the payment terms stated in the applicable order form, proposal, statement of work, invoice, subscription plan, or other written agreement.
Customer is responsible for applicable taxes, duties, and similar governmental assessments associated with its use of the Services, excluding taxes based on Empowerreg’s net income. Empowerreg may suspend or terminate access to paid Services for overdue or unpaid amounts. Empowerreg may modify pricing from time to time; however, any pricing change for an ongoing subscription will not take effect until the next applicable renewal period unless otherwise agreed in writing.
The Services, including all software, applications, dashboards, workflows, reports, data visualizations, documentation, automations, integrations, artificial intelligence-enabled features, models, algorithms, methodologies, trademarks, text, graphics, designs, and related content (collectively, “Our Content”), are owned by or licensed to Empowerreg and are protected by intellectual property laws. Subject to Customer’s compliance with these Terms, Empowerreg grants Customer a limited, non-exclusive, non-transferable, non-sublicensable right to access and use the Services and Our Content solely for Customer’s internal business purposes during the applicable subscription or service term.
Customer may not reproduce, distribute, publish, sell, sublicense, modify, create derivative works from, reverse engineer, decompile, disassemble, or otherwise commercially exploit any portion of the Services except as expressly permitted by Empowerreg in writing. Empowerreg retains all right, title, and interest in and to the Services, Our Content, and all related intellectual property rights. No rights are granted to Customer except as expressly stated in these Terms. Customer is responsible for obtaining and maintaining all rights, licenses, permissions, consents, credentials, and accounts necessary for Empowerreg to access or interact with any third-party services, databases, or data sources authorized by Customer.
The Services may interoperate with, integrate with, or rely upon third-party software, cloud services, APIs, regulatory databases, product-registration databases, public data sources, artificial intelligence providers, quality-management systems, and other third-party products, services, or data sources (collectively, “Third-Party Services”). Third-Party Services are owned and operated by their respective providers. Empowerreg does not own or control Third-Party Services and does not guarantee their availability, accuracy, completeness, timeliness, security, functionality, compatibility, or continued accessibility. The functionality of the Services may depend, in whole or in part, on the availability and operation of Third-Party Services. Empowerreg is not responsible for any outage, disruption, delay, inaccuracy, omission, change in source data, security incident, service interruption, or other issue arising from or relating to any Third-Party Service. Third-party providers are not affiliated with, sponsored by, or endorsing Empowerreg unless expressly stated otherwise.
Certain features of the Services may permit Customer to submit, upload, transmit, integrate, synchronize, or otherwise make available complaints, product information, post-market-surveillance data, adverse-event or vigilance information, risk records, quality records, reports, regulatory information, documentation, prompts, configuration information, account information, and other data or materials (collectively, “Customer Content”). As between Customer and Empowerreg, Customer retains ownership of Customer Content. Customer grants Empowerreg a non-exclusive, worldwide, royalty-free right to access, host, process, reproduce, transmit, analyze, and otherwise use Customer Content solely to provide, maintain, secure, support, and improve the Services and as otherwise permitted by these Terms or the Privacy Policy.
Empowerreg may create and use aggregated or de-identified data derived from Customer Content for service improvement, analytics, benchmarking, and other lawful business purposes, provided that such data does not identify Customer, any individual, or any customer of Customer. Customer represents and warrants that it has all rights, permissions, authorizations, and consents necessary to provide Customer Content and authorize Empowerreg to process it as contemplated by these Terms. Customer is responsible for the accuracy, quality, legality, and appropriateness of Customer Content and for ensuring that its collection, use, disclosure, and submission of Customer Content through the Services complies with applicable law and contractual obligations.
Customer will not provide, and will not permit any Authorized User to provide, protected health information (“PHI”), personal data, or other regulated information through the Services unless: (a) the applicable Service is intended to support the processing of such information; and (b) Customer and Empowerreg have entered into any additional agreement required by applicable law, including a mutually executed business associate agreement (“BAA”) where required, before any such processing occurs. Customer is responsible for determining whether it is subject to HIPAA and whether the information it provides constitutes PHI. If a BAA applies, the BAA governs Empowerreg’s use and disclosure of PHI and controls over any conflicting provision of these Terms.
Empowerreg does not acquire ownership of Customer Content by virtue of these Terms and will not use Customer Content or regulated information to train a general-purpose artificial intelligence model for the benefit of unrelated third parties without Customer’s authorization.
The Services may use machine learning, artificial intelligence, predictive analytics, and other automated technologies to generate reports, analyses, summaries, alerts, classifications, recommendations, risk insights, trend analyses, complaint-management support, reportability-support information, workflow suggestions, and other outputs (collectively, “Outputs”).
Outputs may be incomplete, inaccurate, outdated, misleading, biased, inconsistent, or subject to interpretation. They may vary based on Customer Content, third-party data sources, software updates, integrations, model adjustments, and other factors. Customer acknowledges that artificial intelligence and machine-learning technologies may produce incorrect or unreliable results. Customer is solely responsible for independently reviewing, validating, and determining the appropriateness of all Outputs before relying on them. Without limiting the foregoing, Customer is solely responsible for decisions relating to complaint classification, investigation, reportability, vigilance, adverse-event reporting, regulatory submissions, product safety, risk management, corrective or preventive action, and compliance with applicable laws and regulatory requirements.
Empowerreg does not provide legal, medical, regulatory, clinical, quality-system, or other professional advice. Empowerreg does not guarantee that any Output will be accurate, complete, current, error-free, reliable, available, or fit for a particular purpose. Customer remains solely responsible for all actions taken or not taken based on any Output.
Customer will not, and will not permit any Authorized User or other person to:
Each party may disclose to the other party non-public business, technical, financial, operational, product, security, or other information that is designated as confidential or that reasonably should be understood to be confidential given its nature and the circumstances of disclosure (“Confidential Information”). Empowerreg’s Confidential Information includes the non-public aspects of the Services, including software, workflows, documentation, methodologies, models, and Outputs. Customer’s Confidential Information includes Customer Content and non-public information concerning Customer’s products, quality system, regulatory activities, and business operations. The receiving party will: (a) use the disclosing party’s Confidential Information only as necessary to exercise its rights or perform its obligations under these Terms; (b) protect it using at least reasonable care; and (c) disclose it only to its employees, contractors, professional advisers, and service providers who have a need to know and are bound by confidentiality obligations at least as protective as those in this Section.
Confidential Information does not include information that the receiving party can demonstrate: (i) is or becomes publicly available through no breach of these Terms; (ii) was lawfully known to the receiving party without restriction before disclosure; (iii) is lawfully received from a third party without breach of a confidentiality obligation; or (iv) is independently developed without use of the disclosing party’s Confidential Information. A receiving party may disclose Confidential Information to the extent required by law, regulation, subpoena, or court order, provided that, to the extent legally permitted, it gives the disclosing party prompt notice and reasonably cooperates with efforts to seek confidential treatment.
If Customer provides feedback, comments, suggestions, ideas, enhancement requests, or recommendations regarding the Services (“Feedback”), Customer grants Empowerreg a non-exclusive, worldwide, perpetual, irrevocable, royalty-free, fully paid, sublicensable, and transferable right to use, copy, modify, incorporate, and otherwise exploit that Feedback for any purpose without compensation or obligation to Customer. Feedback does not include Customer Content.
Please review the Empowerreg Privacy Policy at [link] for information about how Empowerreg collects, uses, discloses, and protects personal information. The Privacy Policy is incorporated into these Terms by reference.
The Services may contain links to third-party websites, resources, or content that are not owned or controlled by Empowerreg. These links are provided solely as a convenience and do not constitute an endorsement, sponsorship, or recommendation by Empowerreg. Empowerreg is not responsible for the content, accuracy, availability, security, or practices of third-party websites or resources. Customer’s access to and use of third-party websites or resources is at its own risk and may be subject to separate terms and privacy policies imposed by the applicable third party.
Customer will defend, indemnify, and hold harmless Empowerreg and its affiliates, officers, directors, employees, agents, and representatives from and against any third-party claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys’ fees) arising out of or relating to: (a) Customer Content or Empowerreg’s authorized processing of Customer Content; (b) Customer’s or its Authorized Users’ use of the Services in violation of these Terms or applicable law; (c) Customer’s products, services, quality-system activities, regulatory activities, or decisions; (d) Customer’s failure to investigate, report, classify, document, escalate, or otherwise address a complaint, adverse event, vigilance matter, or other quality or regulatory matter; or (e) Customer’s reliance on or use of any Output without appropriate independent review and validation.
Empowerreg will promptly notify Customer of any indemnified claim and reasonably cooperate with Customer’s defense. Customer may control the defense and settlement of the claim, provided that Customer may not settle any claim in a manner that admits fault by, imposes liability on, or requires action by Empowerreg without Empowerreg’s prior written consent.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICES, OUTPUTS, OUR CONTENT, AND ALL RELATED MATERIALS ARE PROVIDED “AS IS” AND “AS AVAILABLE.” EMPOWERREG DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, ACCURACY, QUIET ENJOYMENT, AND ANY WARRANTIES ARISING FROM COURSE OF DEALING, USAGE, OR TRADE PRACTICE.
WITHOUT LIMITING THE FOREGOING, EMPOWERREG DOES NOT WARRANT THAT THE SERVICES WILL BE UNINTERRUPTED, SECURE, ERROR-FREE, AVAILABLE AT ANY PARTICULAR TIME, OR FREE OF HARMFUL COMPONENTS; THAT CUSTOMER CONTENT, THIRD-PARTY DATA, OR OUTPUTS WILL BE ACCURATE, COMPLETE, CURRENT, OR RELIABLE; OR THAT USE OF THE SERVICES WILL SATISFY ANY REGULATORY, QUALITY-SYSTEM, REPORTING, AUDIT, VALIDATION, CERTIFICATION, OR MARKET-ACCESS REQUIREMENT.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EMPOWERREG WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR FOR ANY LOSS OF PROFITS, REVENUE, DATA, GOODWILL, BUSINESS OPPORTUNITY, CUSTOMER RELATIONSHIPS, OR BUSINESS INTERRUPTION, ARISING OUT OF OR RELATING TO THESE TERMS OR THE SERVICES, WHETHER BASED ON WARRANTY, CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, OR ANY OTHER LEGAL THEORY, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
EMPOWERREG WILL NOT BE LIABLE FOR ANY CLAIM, LOSS, OR DAMAGE ARISING FROM: (A) CUSTOMER’S PRODUCTS, SERVICES, QUALITY SYSTEM, REGULATORY ACTIVITIES, OR DECISIONS; (B) CUSTOMER’S USE OF, OR RELIANCE ON, OUTPUTS; (C) CUSTOMER CONTENT; OR (D) ANY THIRD-PARTY SERVICE OR THIRD-PARTY DATA SOURCE.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EMPOWERREG’S TOTAL LIABILITY ARISING OUT OF OR RELATING TO THESE TERMS OR THE SERVICES WILL NOT EXCEED THE GREATER OF: (I) THE FEES PAID BY CUSTOMER TO EMPOWERREG FOR THE SERVICES GIVING RISE TO THE CLAIM DURING THE TWELVE (12) MONTHS BEFORE THE EVENT GIVING RISE TO LIABILITY; OR (II) ONE HUNDRED U.S. DOLLARS ($100).
Empowerreg may suspend or terminate Customer’s access to the Services or any Account if Customer violates these Terms, fails to pay undisputed amounts when due, or if Empowerreg reasonably believes Customer’s use of the Services creates a legal, security, operational, regulatory, or business risk to Empowerreg, the Services, or another user.
Upon termination, Customer’s right to access and use the Services will cease. Upon Customer’s written request made within thirty (30) days after termination, Empowerreg will make Customer Content available for export in a commercially reasonable format, unless prohibited by applicable law, security requirements, or the terms of an applicable written agreement. After that period, Empowerreg may delete Customer Content in accordance with its then-current data-retention practices, subject to applicable law and any written agreement between the parties.
Sections that by their nature should survive termination will survive, including those relating to intellectual property, confidentiality, feedback, fees, indemnification, disclaimers, limitations of liability, dispute resolution, and governing law.
Before initiating a legal proceeding, the parties will attempt in good faith to resolve any dispute arising out of or relating to these Terms, the Privacy Policy, or the Services by providing written notice to the other party and engaging in informal discussions for at least thirty (30) days. If the parties do not resolve the dispute informally, the dispute will be resolved by binding arbitration administered by the American Arbitration Association under its Commercial Arbitration Rules. The arbitration will take place in King County, Washington, unless the parties agree otherwise.
Either party may seek temporary, preliminary, or permanent injunctive or other equitable relief in a court of competent jurisdiction to prevent or remedy actual or threatened misuse of its intellectual property, Confidential Information, or other proprietary rights. Empowerreg may also pursue claims for unpaid fees or collection-related matters in a court of competent jurisdiction. If a dispute is determined not to be subject to arbitration, the state and federal courts located in King County, Washington will have exclusive jurisdiction. Each party will bear its own attorneys’ fees and costs, except as otherwise required by law or awarded by the arbitrator.
These Terms and any dispute arising out of or relating to these Terms or the Services are governed by the laws of the State of Washington, without regard to its conflict-of-laws principles, except that the arbitration provision is governed by the Federal Arbitration Act.
Questions or notices for Empowerreg may be sent to:
Empowerreg Corp.
[Mailing Address]
Email: [–]
These Terms, together with the Privacy Policy and any applicable order form, statement of work, or other written agreement between Customer and Empowerreg, constitute the entire agreement between the parties regarding the Services. If a separately signed written agreement expressly conflicts with these Terms, that written agreement controls to the extent of the conflict. Customer may not assign or transfer these Terms, by operation of law or otherwise, without Empowerreg’s prior written consent. Empowerreg may assign these Terms in connection with a merger, acquisition, corporate reorganization, or sale of all or substantially all of its assets. Notices from Empowerreg may be provided by email, through the Services, or by other reasonable means. Empowerreg’s failure to enforce any provision of these Terms is not a waiver of that provision. If any provision of these Terms is held invalid or unenforceable, the remaining provisions will remain in effect, and the invalid or unenforceable provision will be enforced to the maximum extent permitted by law.
