Resource library

Medical-Device Resources

Medical-device manufacturing guides, an eight-question software evaluation checklist, glossary essentials and an illustrated production workflow.

Guides: 8 guides
Glossary: 6 glossary entries
Checklist: 8 buyer questions

Materials, Kitting & Supplier Evidence

Follow component lots from receiving and supplier evidence into a controlled build.

GuideMedical Device Inventory ManagementManufacturer receiving, material status and component lots.Read the guide
GuideWarehouse Quality ControlReceiving checks, holds and release of stock.Open
GlossaryMedical Device KittingKit assembly and component genealogy.Open

Design Transfer, Build Records & Release

Move an approved design into production and keep the executed record reviewable.

Identification & Traceability

Keep the identifier on the unit linked to the record of how it was built.

Implementation & Quality-System Reference

Separate execution and business-system responsibilities, and keep the current US framework straight.

Software Pages

Continue to the existing product information for your evaluation.

Evaluate the software

Work through these questions with your production and quality teams, then use them to plan an evaluation with your own records.

Component & Lot EligibilityHow will we show which component lots are eligible for a build, including status, expiry and supplier evidence?

Controlled Build RevisionHow will each build identify the approved instruction revision actually used, including changes during work in progress?

Operator & Instrument ReadinessWhat evidence will show operator readiness and instrument calibration or service status at the relevant step?

Inspection & NonconformanceHow will inspections, exceptions and nonconforming product reach the people responsible for disposition?

Actual Genealogy & ReworkCan we demonstrate component-to-finished-device genealogy, including lot splits, substitutions and rework relevant to our process?

Accountable Release EvidenceWhat record will our authorised reviewer use to make and document the release decision?

Integration & System OwnershipWhich system owns each record, what connections need configuration, and who handles failures or reconciliation?

Intended-Use ImplementationWhat implementation, testing and validation evidence does our intended use require, and which responsibilities belong to us or the supplier?

The existing 32-page production guide and its worksheets remain behind the email gate; the guide opens online for printing. Open the existing guide offer.

Explore the workflow

The illustrated five-step workflow follows component delivery, assembly, inspection, record review and shipment.

Explore the medical devices workflow