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When working with a translation company certified to the ISO 13485:2003 standard, medical device companies can look to reduce cost and improve risk mitigation with regards to Notified Body Inspection. Furthermore, they should experience fewer Supplier Control non-conformities during ISO 13485 audits. Below are some of the primary reasons why more and more medical device companies opt to outsource their medical translations to an ISO 13485-certified translation company.

QMS Harmonization

The quality system of the medical device manufacturer and the quality system of the ISO 13485-certified translation partner will be seamlessly integrated and harmonized.

Audits

By outsourcing their medical translations to an ISO 13485-certified translation company, medical device manufacturers will reduce cost and improve risk mitigation during their ISO 13485 audits.

Translation Vendor Qualification

Medical device manufacturers can introduce a shorter qualifying process and significantly reduce their resource allocation for supplier qualification and control.