ISO 13485 Certification

Clinitrans is one of only two translation firms in the world to be certified for ISO 9001-2000 for a translation quality management system focused on continuous quality improvement and ISO 13485-2003, which is specifically designed for medical device regulatory requirements.

Our ISO:13485 Translation Quality Management system for medical device manufacturers provides a regularly audited procedure to ensure compliance for C-mark, MDD, IVDD and other labeling requirements.

At 1-800-Translate, quality assurance planning is incorporated at every translation milestone to successfully deliver a localized product that meets the expectations of client, compliance officers, regulators and the intended audience. Projects are supervised by a cadre of linguists and an experienced project management team specifically assembled for the client’s particular requirement. Our team of linguists are tested, trained and audited in compliance with strict ISO requirements.

We have special expertise in clinical trial, documentation, inserts and labeling for orthopedic, cardio, and ophthalmological medical device manufacturers. And we provide the same level of service to a broad range of biomedical and device manufacturers. High quality, low risk translation, and a great customer experience are demonstrated by our ISO compliance and backed by an audited measure of client satisfaction.

Since the method of ISO compliance is specific to each firm, and certification only requires that a quality assurance process is implemented and documented, the actual success of any ISO-certified process is measured in terms of client satisfaction. We measure our clients’ satisfaction using a one-question survey after the completion of each job, an audited client satisfaction index known as NPS (Net Promoter Score).

This is how we measure the success of our ISO 9001 quality assurance management process. In fact, part of what makes us unique in the translation industry is that we actually publish our NPS score on a quarterly basis and why 1-800-Translate is ranked first for customer satisfaction among North American translation services.