Legal Status
ISO Cloud Consulting operates as a South African private company incorporated under the Companies Act 71 of 2008. For US clients, the organisation functions as a foreign service provider governed by Missouri contract law (RSMo Title XXVI) where applicable by agreement.
All consulting outputs—QMS documentation, regulatory frameworks, technical documentation, validation packs—are delivered as advisory professional services.
Terms of Service
Contract Formation
A binding service agreement is established upon acceptance of a quotation, execution of a formal proposal, written confirmation, or payment of fees.
Regulatory Context
Services relate to ISO 13485, ISO 14971, EU MDR/IVDR, FDA QMSR and other relevant statutes. This includes interpretation and application of internationally recognised frameworks, not legal advice.
Reference standards include:
– ISO 13485:2016 (Quality management systems)
– ISO 14971:2007 (Risk management)
Jurisdiction
For South African clients: governed by South African law, including the Companies Act 71 of 2008 and the Consumer Protection Act 68 of 2008.
For Missouri or US clients: governed by the laws of the State of Missouri (RSMo Title XXVI—Contracts and Indebtedness).
Use Obligations
Clients must provide accurate and complete information. Deliverables must be used responsibly within their regulatory context. Altering templates without appropriate qualification, verification or validation is at the client’s own risk.
Liability
Liability is limited to the total fees paid for the services giving rise to the claim, to the maximum extent allowed under Missouri and South African law.
NDA Availability
Clients requiring confidentiality beyond standard commercial privacy protections may request execution of a formal Non-Disclosure Agreement. A standard NDA template is provided below for immediate use.
Privacy Policy
Legal Alignment
– POPIA (South Africa)
– GDPR (EU)
– Standard US federal privacy expectations (Missouri has no state-level privacy statute)
Data Collected
Identification details, company information, project data, analytics, IP addresses, billing metadata, and correspondence.
Purpose of Processing
Service delivery, documentation development, regulatory mapping, validation work, billing, analytics, and compliance retention.
Data Storage & Transfers
Cross-border transfers between South Africa, the US (including Missouri), the EU, and other regions are executed with appropriate safeguards.
User Rights
POPIA: access, correction, deletion, objection.
GDPR: access, rectification, erasure, restriction, objection, portability.
Cookies & Tracking
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