ISO Certificates — Which Standard, Which Scope
When a buyer says "ISO", at least five different standards could be meant. The quality system is ISO 13485; autoinjector performance is tested to ISO 11608-5; patient-contacting materials follow ISO 10993-1. The table below maps each one to the document that actually proves it, so your RA team knows what to ask for and what it will — and will not — show. Certificates and test reports are released with the order documentation once an order is confirmed; before that we confirm the scope in writing, which is the part that decides whether the certificate is relevant to you at all.
| Buyer says | Standard | What the document has to show |
|---|---|---|
| "ISO certified" | 13485 — quality management system | Certificate number, issuing body, validity, and the scope text verbatim |
| "ISO 11608" | 11608-5 — needle-based autoinjector performance | The test report and which parts were tested |
| "Biocompatibility" | 10993-1 — biological evaluation | Which contact materials, which endpoints |
| "Needle safety" | 23908 — sharp-protection requirements | Test method and results for the shield feature |
| "Label symbols" | 15223-1 — symbols for medical device labels | Symbols list used on packaging and IFU |
When these documents are released. Certificates and test reports go out with the order documentation — after an order is confirmed, together with the supply agreement. They are not issued at the enquiry stage. What you get before that decision is the substance without the paper: a written statement of which standards apply to the platform you are evaluating, which entity holds each certificate, its certificate number, issuing body and validity date, and the scope wording quoted in the message itself.
What we do not hold
We do not hold every certificate in the chain, and the order documentation says which ones we hold and which sit elsewhere — including where that is a manufacturing partner rather than NOVIXPEN. Stating the boundary of a claim is not a weakness in a regulatory conversation — it is the difference between a supplier who gets audited once and a supplier who gets audited twice.
How to verify us
Verification runs in two stages. Before an order: we put the holder, certificate number, issuing body, validity date and scope wording in writing, and you check that entry in the issuing body's public registry yourself — that costs nothing and releases no document. After the order: the full set arrives with the order documentation, each certificate as a copy with the scope text verbatim, plus the test reports behind every performance line on the specifications page.
This page does not cover
Market-specific registration paths (FDA clearance status, CE marking route, or national registrations) are product- and market-specific and will be stated separately with their own evidence. Device documentation feeds your submission; it does not replace it. Combination-product strategy belongs to your regulatory team — see the compatibility page for the document list we contribute.
Confirm the compliance scope for your platform
Send the platform and target market you are evaluating. Before any order we put in writing which standards apply, which entity holds each certificate and what the order documentation will contain — so your RA team can judge relevance, not just existence.
Ask about compliance scope