ISO 13485:2016 Questions to Ask Device Suppliers
A certificate on a website is not a quality system. Procurement and supplier quality teams need questions that reveal whether a vascular device partner can survive a notified body audit — and your own vendor review.
Scope statement specifics
Ask for the exact ISO 13485:2016 scope covering guidewire tipping, introducer assembly, or kit packaging. Out-of-scope processes outsourced without control become your CAPA problem.
Design control evidence
OEM modifications require design inputs, verification, and change control. Request a redacted DHF index for a representative SKU similar to your project.
MDSAP jurisdiction alignment
MDSAP certifications in Australia, Brazil, Canada, and the United States reduce duplicate audits if you sell into multiple markets. Confirm certificate currency and audit grades.
Sterile vs non-sterile release paths
Bulk non-sterile release should still have contamination controls. Sterile release needs validated sterilization cycles — ask which method applies to your SKU.
CAPA and complaint trending
Request aggregate complaint rates by product family with corrective action closure times. Spikes in tip separation or coil unwind warrant engineering review before you scale PO volume.
Pending MDR transition
With MDR certification pending for many legacy portfolios, ask for transition timelines and whether your SKU depends on MDD class II/III certificates today.
American Medical Supply aligns quality narratives to FDA registered and ISO 13485:2016 operations — use these questions to compare any new entrant fairly.