Industry
Regulated, traceable, validated, exacting. The operational discipline transfers.
ISO 13485 manufacturers and contract producers — the manufacturing-rigor layer underneath your regulatory partners.
ISO 13485 medical device manufacturers operate under a quality regime that demands documentation rigor, validation, and traceability. The operational disciplines transfer from regulated manufacturing in adjacent verticals — ammunition, aerospace — almost directly. The terminology is different. The methodology is the same.
We do not claim deep clinical or regulatory expertise in FDA submissions. We do claim operational expertise, documentation reality, and the kind of manufacturing discipline that makes ISO 13485 audits a non-event.
Quick answer
Brass & Bench works ISO 13485 medical device manufacturers and contract producers as the operational and manufacturing rigor layer underneath their FDA, regulatory, and clinical partners. The team handles ISO 13485 documentation-to-floor reality checks, industrial engineering for precision assembly and machining, insurance audit tuned to device product liability, acquisition readiness, and custom software for traceability, validation documentation, and complaint management. We do not provide FDA submission, clinical affairs, or new-device regulatory strategy, refer to specialist firms for those.
By Lorrie Lynn · Founding Partner — Operations, Manufacturing & International Contracts · Updated May 14, 2026Regulatory layer
The compliance reality.
ISO 13485 quality management. FDA 21 CFR Part 820 (QSR). EU MDR for European market. UDI (Unique Device Identification) compliance. Process validation (IQ/OQ/PQ). Design controls. CAPA. Complaint handling and MDR reporting. Sterilization validation where applicable. Contract manufacturing flowdown obligations.