IMSQ · Institute of MedTech Software Quality
Legal

Customer Decision Acknowledgement

Advisory Boundary Clause · AG-06Attached to every advisory output

The Customer Decision Acknowledgement (CDA) is the non-guarantee footer attached to every IMSQ advisory output. It records, in writing, that final regulated decisions remain the customer’s responsibility. This is the human-readable version of the clause that appears on each Advisory Summary.

Draft · pending legal counsel review ›This page is draft plain-language summary copy shown for review. The final wording is pending legal counsel and will be confirmed before launch or customer signing. It is not the binding contract text.

What an advisory is

An Advisory Summary captures structured recommendations from a named Expert, together with the assumptions and limitations behind them. It is professional input to your decision — not a regulatory decision, approval, or guarantee.

What you acknowledge

By engaging on advisory work you acknowledge that: you retain ownership of your QMS and process control; you make the final regulatory and quality decisions; and you remain responsible for how any recommendation is applied to your product and submissions.

What IMSQ and Experts do not do

IMSQ does not author or approve your design controls, risk files, V&V plans, or submissions, and does not guarantee audit outcomes or regulatory approval. Independent Experts provide advisory opinions and specialist judgement; they do not make regulatory decisions on your behalf.

Named attribution & traceability

Every advisory output carries the named Expert’s identity and qualifications, a timestamp, and the assumptions and limitations of the advice. This maps directly into your supplier-control records and ISO 13485 §7.4 file.

Where this appears

The CDA footer is auto-attached to every Advisory Summary (AG-03) and is referenced in the Supplier Qualification Pack (AG-05). Signing an advisory records your acknowledgement of this clause against the audit ledger.

This page is a plain-language summary and is not legal advice. For subscribed organisations, the binding contract text is the order form and master agreement executed with your organisation, which take precedence wherever they differ.

Questions about the fine print?

Procurement and legal reviews are welcome. Book a programme review and we’ll walk your team through the terms, the SLA, and the Supplier Qualification Pack.