Due to compliance implications with the requirements of the Medical Device Directive (MDD), Notified Bodies consider the outsourcing of translation services to be a critical outsourced service. Such Notified Bodies also consider that translation companies should be “approved vendors.” This makes translation suppliers subject to the outsourced vendor risk management considerations of ISO 13485.
Certified Outsourced Service is Preferred to In-House Translation
This is the reason why, when it comes to translation services, Notified Bodies recommend that medical device manufacturers select translation companies that are certified to the ISO 13485 standard. By working with ISO 13425-certified translation companies, medical device organizations can reduce costs and lower risks regarding Notified Body Inspections, and likely minimize the number of non-conformities during the audit process.
Below are some of the primary reasons why more and more medical device companies opt to outsource their medical translation services to ISO 13485-certified translation companies.
- QMS Harmonization — The quality system of the medical device manufacturer and the quality system of the ISO 13485-certified translation companies will be seamlessly integrated and harmonized.
- Audits — By outsourcing their certified translation services to an ISO 13485-certified translation supplier, medical device manufacturers can improve risk mitigation during their ISO 13485 audits.
- Translation Vendor Qualification — Medical device manufacturers can introduce a shorter qualifying process and significantly reduce their resource allocation for supplier qualification and control.
In addition to the ISO 13485 certification, the selected translation companies should also be certified to the ISO 17100 standard. It is a quality standard for technical, medical, and life sciences translation services. ISO 17100:2015 provides requirements for the core processes, resources, and other aspects necessary for the delivery of quality translation services that meet applicable specifications.
A Standard Specifically Designed for the Translation Industry
ISO 17100 is a standard specifically designed with the translation industry in mind, including medical translation companies. It covers all aspects of the translation process and defines basic parameters for a quality translation process. ISO 17100 demystifies and explains the critical components associated with translation services.
ISO 17100 standardizes terminology, defines basic requirements for translation services, and creates a framework for interaction between customers and translation companies. ISO 17100 offers clients guidance to the services offered by certified translation companies, especially for those suppliers that are new to translation or about to enter a foreign market. ISO 17100 also provides clients with a reference point (a benchmark) for quality. The standard is widely used as a tool to evaluate translation companies and assess their quality performance.
Adherence to and maintenance of an ISO 17100 certification is an ongoing process which requires company resources. An outsourced service provider that specializes in translations can easily justify the cost of maintaining certifications. This is why an outsourced service provider with the right credentials and experience will outshine in-house solutions. A small department of a company that does not natively do translations, or a dedicated, specialized agency.
About Excel Translations, Inc.
Excel Translations is the market leader in ISO 9001-, ISO 13485- and ISO 17100-certified medical translation services. Since 1996, Excel Translations has been specializing in the globalization needs of regulated companies in the life sciences and healthcare industries. We work with Fortune 1000 companies in the Medical Device Manufacturing, Biotechnology, IVD, and Pharmaceutical industries as well as with Contract Research Organization (CROs) and have tailored our ISO 9001, ISO 13485 and ISO 17100 translation processes to meet the specific requirements of these industries. We have become the preferred translation partner of life sciences and healthcare companies, large and small, in the US, Asia and Europe.