Fasteners Manufacturer
for Israel
Mumbai · India

ISO 13485 is the quality management standard specific to medical device manufacturing — built on similar foundations to ISO 9001 but with additional, industry-specific requirements around risk management, design controls, and full product traceability throughout the supply chain. For a fastener component supplier, the practical significance shows up in the documentation and traceability expectations that medical device manufacturers typically pass down to their component suppliers, even where the supplier itself isn’t directly ISO 13485 certified.

The most relevant of these for fastener supply is complete lot and heat traceability — the ability to trace any supplied component back to its specific raw material heat number, manufacturing lot, and inspection records, supporting the medical device manufacturer’s own regulatory documentation and, where required, any downstream corrective action or recall investigation. Material certification confirming exact grade and composition — particularly relevant for stainless components used in reusable surgical instruments or device housings — is typically expected as standard, not an optional extra.

Akbar Fasteners’ documentation practices are structured to support this level of traceability — full MTC with heat number reference, NABL-accredited material testing, and lot-level record keeping across our stainless and exotic alloy range. We’re glad to discuss specific traceability or documentation requirements for a medical device component supply program when quoting.