It just makes sense that the text you choose to include in your most important medical product documents (i.e. IFUs, User/Operator’s Manuals, Labels, Technical Specifications, Drug Indications, etc) is critical to the overall quality of how the product is used and prescribed. Words and phrases are carefully selected so that the information is precisely communicated.
Industry best practices dictate that the translation of these documents and text be treated with the same importance. It is an internal requirement for many leading drug and device manufacturers that the medical translation partner they select not only has the experience and expertise in the medical industry, but also has the certifications to back it up.
Now we are seeing this requirement communicated from an authoritative medical industry body. Recently the NBOG (Notified Bodies Operations Group) released a guidance that listed translation services as critical to quality. NBOG has begun to audit international certification organizations, such as BSI, TUV SUD, TUV Rhineland and others, more stringently regarding the manufacturers they register and certify. Where the NBOG is tightening their belt specifically refers to the quality of how and with whom translations are done.
In turn, international testing organizations must audit the manufacturers to the standard that the NBOG dictates. Audits will now require manufacturers to speak to the quality of their medical translations including how they vet and qualify the experience of the translation partner with whom they work. Manufacturers who work with translation partners with specific experience and expertise in the medical industry and can show proof of their vendors’ expertise and experience, will have little to no problems with this critical item during audits. Manufacturers who work with translation partners who are both ISO 9001 certified and ISO 13485 certified will have this burden of proof through the ISO certificates they have on file from their translation vendors.