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ISO 13485

FORGINAL medical is certified in accordance with ISO 13485 for the following field: “drop forging of steel and alloy parts in small and medium series for medical devices“.

ISO 13485 sets out the requirements for the quality management system when an organisation has to demonstrate its ability to regularly supply medical devices and associated services in line with customers’ requirements and the regulatory requirements applicable to medical devices and associated services.

FORGINAL medical applies a policy of constant rigour in its practices to ensure total traceability, robust manufacturing and testing processes, optimum risk management and absence of contamination of the products supplied. The greatest transparency is necessary. All relevant documents are archived for 35 years.

FORGINAL medical works with a list of suppliers and subcontractors who have been qualified according to quality and lead time criteria. The raw material is purchased only from European or US manufacturers in accordance with the standards in this field (ASTM F136, ISO 5832, ETTC, ISO 20160, etc.). All batches of raw materials received are tested and validated before use.