Intertranslations are delighted to announce that they have recently acquired the international standards certification, ISO 13485:2016. The preferred medical device standard within the medical industry, this international standard ensures that all medical devices comply with legal regulations and customer requirements.
The ISO 13485:2016 specifies the requirements for a quality management system (QMS) where organisations must demonstrate their ability to deliver medical devices that consistently meet customer and regulatory requirements. These organisations can be involved in any stage of a medical device’s life cycle, from design, development and production to storage, distribution and installation. It can even apply to servicing and other related services such as technical support.
The value of ISO 13485:2016 is found both in its practical applications and as an auditing tool for testing the effectiveness of an organisation’s QMS. This gives manufacturers more confidence in their ability to achieve and maintain regulatory compliance on a consistent basis. As a result, it also helps them avoid unwanted surprises and failures that could compromise patient safety and harm their reputation.
Intertranslations have been helping major medical device companies meet regulatory and export requirements since 1996. During the course of the last 25 years, they have translated hundreds of thousands of pages in over 350 language combinations. Working with clients in the life sciences industry, they provide accurate, high-quality translations of technical documents, labelling and other content required for medical devices.
Their scientific translators have diverse academic and professional backgrounds, ranging from physicians and health care professionals to technical writers in the medical device industry. By only hiring native linguists with a successful track record that demonstrates their expertise, they will ensure the quality of your medical device translations.