We are very excited to announce that translate plus has become independently accredited to ISO 13485. ISO 13485 is an international standard that demonstrates quality in the medical devices industry. For any company involved in the design, production, installation, servicing, global distribution and any related service of medical device products, including medical translation providers, it is the most accepted international standard of its kind.
To become certified to ISO 13485, our existing operational procedures related to quality management of medical device translations underwent a stringent internal audit by an independent third party and were found to comply with all regulatory requirements and quality practices.
In the medical devices industry, where safety and quality are non-negotiable, medical device and healthcare providers need to adhere to an exemplary quality management system, demonstrating best practices at every step of a medical product’s lifecycle – from conception and early design to manufacturing and global distribution.
“Through becoming certified to ISO 13485, we demonstrate our commitment to safety and quality for medical device translations by adhering to the same standards our Medical Device, Pharma and Healthcare clients also adhere to, achieving full alignment with their translation quality needs and the QMS practices of the medical devices industry. In addition, by holding this standard we show our dedication to continuously improving such practices for greater operational efficiency and project outcomes, ultimately contributing to better user experiences of such products.” – Liina Thorn, Client Services Director at translate plus.
ISO 13485 comes as an addition to our existing ISO 9001, 14001, 17100 and 18587 certifications, for which are audited every year.
For further information and to inquire about our ISO-certified translation services, please contact us.