ISO 13485–ready traceability
Unify parts, design BOMs, SBOMs, suppliers, and audit evidence in one place. Built for teams who need release discipline, not another generic PLM maze.
Built for regulated workflows
One workspace from part master to released device—so your QMS story matches how the product is actually built.
Approve, obsolete, and trace every component with clear state—no mystery part numbers.
Structure assemblies, revisions, and design BOMs so engineering and QA speak one language.
Export SBOMs and map components to risk and verification without duct-taped spreadsheets.
Keep supplier context beside the BOM and preserve an evidence trail for audits.
OPRA Build keeps your BOM universe aligned with how regulated teams actually work—structured, searchable, and release-ready.