Layer Trace

Terms of Sale and Legal Disclaimer

1. Nature of Products and Services Provided 

    Layer Trace (the “Company”) operates strictly as a digital publisher of pre-formatted document templates, framework guides, and educational materials relating to software documentation structures (such as IEC 62304).

    • No Consulting Services: Layer Trace is not a regulatory affairs agency, legal counsel, or Quality Management System (QMS) consultancy. Purchasing products from this website does not establish a professional consultant-client relationship.
    • No Personalized Advice: The Company does not review your specific medical device, source code, clinical intent, or engineering environment. Any support provided via email or documentation is strictly limited to technical template usage, file access, and formatting assistance.

    2. Regulatory Registration & Compliance Disclaimer

      Medical device regulation is highly complex and dependent on your specific hardware, country of origin, target market, clinical indications, and software safety classification.

      • No Warranties of Compliance: Layer Trace products are sold “AS IS” and without any explicit or implied warranty of fitness for a particular regulatory purpose. The Company makes no guarantee that these templates will pass an internal audit, external notified body review, TGA assessment, FDA submission, or CE mark verification.
      • Template Customisation Required: The buyer acknowledges that a template is an empty structural shell. It is the sole responsibility of the buyer to populate, modify, audit, and adapt all templates to align with their unique corporate Quality Management System (QMS), risk management files, and applicable regional laws.

      3. Australian Consumer Law Rights & Limitation of Liability

        Our goods come with guarantees that cannot be excluded under the Australian Consumer Law (contained in Schedule 2 of the Competition and Consumer Act 2010 (Cth)) [1].

        • Exclusion of Implied Terms: To the full extent permitted by law, all implied conditions, warranties, representations, or guarantees not expressly stated in these Terms are excluded.
        • Limitation of Liability for Guarantees: Where legislation implies a consumer guarantee or condition under the Australian Consumer Law which cannot be legally excluded, the Company’s liability for any breach of such guarantee or condition is strictly limited, at the Company’s sole discretion, to:
          1. The replacement of the digital goods or the supply of equivalent digital goods; or
          2. The payment of the cost of having the digital goods replaced or re-supplied.
        • Financial Liability Cap: To the maximum extent permitted by law, in no event shall the total collective liability of Layer Trace for any direct, indirect, incidental, or consequential damages exceed the exact dollar amount paid by the customer for the specific template package out of which the liability arose.
        • Indemnification: By completing a purchase, the buyer agrees to defend, indemnify, and hold harmless Layer Trace from any claims, regulatory penalties, product recalls, lawsuits, or expenses arising from the development, marketing, clinical use, or regulatory submission of the buyer’s medical device software.

        4. Intellectual Property & Usage License 

          When you purchase a downloadable file pack from Layer Trace, you are buying a Commercial Use License, not the underlying intellectual property.

          • Permitted Use: The buyer is granted a non-exclusive, non-transferable, perpetual license to use, modify, edit, and populate the templates for the internal business operations and regulatory submissions of a single corporate entity.
          • Prohibited Use: The buyer strictly agrees not to resell, redistribute, sub-license, copy, upload to public repositories, or share the empty or unpopulated templates with any third party, external consultant networks, or competing businesses.

          5. Digital Delivery & Refund Policy

            Due to the instant, downloadable nature of digital goods, Layer Trace does not offer refunds or cancellations for a change of mind once a purchase is completed.

            • Major Failures: In accordance with Australian Consumer Law, if a digital asset suffers from a major failure (e.g., the file is permanently corrupted, cannot be opened, or is fundamentally different from what was described or pictured on the product page), you are entitled to a replacement file or a full refund if the defect cannot be remedied by our technical support within a reasonable timeframe.

            6. Governing Law & Jurisdiction

              These Terms of Sale and any disputes arising out of or in connection with the purchase of Layer Trace products are governed by and construed in accordance with the laws of Western Australia, Australia. The buyer irrevocably submits to the exclusive jurisdiction of the courts of Western Australia and courts authorized to hear appeals from them.