Legal
Terms, Conditions & Service Disclaimer
Effective for all services provided by VORTEX Biomedical LLC
VORTEX Biomedical LLC provides biomedical equipment service support, technical consulting, documentation support, regulatory pathway support, and medical technology project support. The following terms and disclaimers apply to all services.
No Legal, Clinical, or Regulatory Guarantee
VORTEX Biomedical LLC does not provide legal advice, clinical care, medical diagnosis, FDA clearance guarantees, FDA approval guarantees, reimbursement guarantees, or regulatory outcome guarantees. Regulatory, FDA, 510(k), De Novo, quality system, design control, risk management, verification, validation, and technical documentation services are provided as consulting and documentation support only. Final regulatory strategy, submission responsibility, product claims, labeling, compliance decisions, and submission ownership remain with the manufacturer, sponsor, specification developer, or legally responsible party.
No OEM Authorization Unless Stated
VORTEX Biomedical LLC is an independent service and consulting provider. VORTEX does not represent itself as an OEM-authorized, manufacturer-certified, or manufacturer-affiliated service provider unless such authorization is expressly documented in writing.
Equipment Service Scope
Equipment service is limited to troubleshooting, inspection, maintenance support, repair support, electrical safety analysis, documentation, functional verification, and work described in the approved quote, purchase order, service report, statement of work, or written agreement.
No Remanufacturing / No Intended Use Change
VORTEX Biomedical LLC does not remanufacture medical devices, alter intended use, relabel devices, or materially change device safety or performance specifications unless such work is separately evaluated and documented under applicable regulatory requirements.
Parts and Software
VORTEX does not guarantee that customer-supplied parts, third-party parts, refurbished parts, recycled components, unsupported software, missing software, corrupted storage media, or obsolete equipment will restore equipment to full operational condition. When OEM/source parts or licensed software are required, the customer is responsible for obtaining appropriate parts, licenses, and approvals unless otherwise agreed in writing.
Service Results
Service findings and test results reflect the equipment condition at the time of service. Future failures, misuse, unauthorized modifications, environmental conditions, facility power issues, network issues, prior repairs, third-party parts, software corruption, or unrelated system conditions are outside the service scope unless expressly documented.
Customer Responsibility
The customer is responsible for confirming equipment ownership, service authorization, site access, purchase order approval, parts availability, software/licensing rights, and whether equipment may be returned to use under the customer's internal policies and applicable regulatory requirements.
Limitation of Liability
To the maximum extent permitted by law, VORTEX Biomedical LLC is not liable for indirect, incidental, consequential, special, punitive, lost revenue, lost profit, downtime, loss of data, loss of use, replacement equipment, or business interruption damages. Any liability is limited to the amount paid for the specific service giving rise to the claim, unless prohibited by law.
Payment Terms
Payment is due according to the invoice, purchase order, quote, or written agreement. Vendor onboarding delays, missing PO information, administrative delays, or internal customer processing delays do not waive payment for completed work.
Work is limited to the approved service scope. VORTEX Biomedical LLC provides independent biomedical equipment service and technical consulting; no legal advice, clinical care, OEM authorization, FDA clearance/approval guarantee, remanufacturing, or intended-use change is provided unless expressly documented in writing.
Project-specific quotes, service reports, statements of work, purchase orders, and written agreements control over general website terms.
← Request Service