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ISO 13485

ISO 13485 — Medical Devices Quality Management · issued by ISO

What it certifies

Quality management for medical device manufacture.

Why a buyer should care

Not aerospace, but indicates the supplier is used to regulated manufacture, traceability and design control.

Typically required for

Medical device manufacture.

Suppliers claiming it (5)

These are claims published by the suppliers themselves. We have not seen the certificates. Always ask for a current certificate and its scope before placing work.