Medical Translation Insight

Medical device and IVD manufacturers are subject to a veritable alphabet soup of quality standards. In an effort to align themselves closer with their clients, medical translation companies are assessing the pros and cons of expanding their own certifications.

After ISO 9001, the certification that is most requested is for ISO 13485:2003, the quality management standard designed for medical device companies and their critical suppliers. In response, we have updated ForeignExchange's quality system to be fully compatible with ISO 13485.

And last week, we successfully completed our first ISO 13485 audit. Some of the findings from the two-day audit highlight key strengths in ForeignExchange's approach to providing quality translation services, including:

• Exceeding on delivery deadlines
• Paid training for some employees demonstrated
• ForeignExchange's comprehensive client satisfaction survey
• Excellent data gathering throughout the organization
• Strong commitment to an effective QMS

We are excited about this important step. In combination with our existing ISO 9001:2008 [PDF link] and EN 15038:2006 certifications, adding ISO 13485 demonstrates ForeignExchange's wish to make it as easy as possible for device companies to work with us.

One big factor in this is that incoming inspection is less burdensome if a supplier is certified to ISO 13485. While ISO 9001 is focused on continuous improvement, ISO 13485 aims to "get it right from the start". And that makes ISO 13485 very relevant for medical translation service providers.


ForeignExchange is the only company that provides clients with measurable translation quality. Our METRiQ quality system provides medical device and pharmaceutical companies with known translation quality - on every assignment. Find out more!