ISO 13485:2003
"Due to compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an 'important outsourced service'…This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971." - KEMA
ISO 13485:2003 Advantages
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.
