Medical Device Translation
Translation for medical and surgical device manufacturers is increasingly perceived by regulators and Notified Bodies as a key outsourcing activity. Issues related to outsourcing and supplier control are at the core of the ISO 13485 standard. This is one of the primary reasons why more and more device companies are outsourcing their medical translations to ISO 13485-certified translation companies. This is also the reason why in 2008, Excel Translations has made the necessary investment to become ISO 13485:2003-certified, effectively aligning its quality processes with its clients' in the medical device, diagnostic, hospital supply, and dental supply industries. Follow this link to understand why this certification is important to medical device manufacturers. BSI Management Systems America, Inc., a leading global provider of management systems assessment and certification solutions, awarded Excel Translations the ISO 13485 certification for its translation services in 2008.
Device companies should also be aware of the requirements of Directive 2007/47/EC and learn about instances when software is now considered a medical device, what has changed for European market clearance, why software needs to be translated before the March 2010 deadline, what they need to do to be compliant before March 2010, and how we can help schedule their transition to full compliance.
Since 1996, Excel Translations has provided expert medical device translation services to medical device companies such as Abbott Vascular (formerly Guidant), Medrad, Volcano Corporation, and Nipro Diagnostics amongst others.
