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As originally asked by Khaled Hamza.

I am curious to know, does the manufacturing company handles language part when exporting to out of home markets, or its the agent (distributor) is the one who handles this?

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Khaled Hamza
Business Development – Key Accounts – New Bushiness – MENA – Gulf
Thank you Vanessa , I know MBI since over 9 years ago 🙂

Vanessa Lontoc, MBA
Tech-savvy, creative, marketing professional with 10+ years experience and quantifiable achievements.
Depending on the country, there are product labelling regulations (and many other type of regulations) that you need to take in account. The manufacturer itself does not have to internally translate as mentioned by most peers here. Also, some countries require that the translator are sworn or certified.

I work for Merrill Brink International and we have industry ISO and EN certifications and registrations.

Khaled Hamza
Business Development – Key Accounts – New Bushiness – MENA – Gulf
Thank you all for the comments and positive input.

Mario Martinez
Managing Partner at Tecnix, LLC
Localization is probably more important than simple translation. The key point is that the target-language version will often not be a literal translation. As an example, to convey the phrase in Spanish “Fly in Leather” a literal translation would be “Fly Naked” Or a translation that uses the word “Senorita” when referring to an unmarried woman in some contexts translates into “Virgin”.

As to the distributor doing the translation more than likely he owns the registration unless your company has a local entity or agent and took steps to secure the registration and brand in the country. The distributor is often required to change the labeling to reflect the registered agent which will often put your marketing and regulatory departments in Apoplexy if they only took the time to read the final literature which often they don’t unless you have a dedicated team for the region or good agent that is independent from the distributor.

Eduardo Parker
Medical Laser Technology Aficionado
I´ve been translating medical laser user manuals , service manuals and treatment guide manuals for over 25 years into spanish / castillian. I can tell you that more important than doing this through a certified translator which covers the burocratic process (whistles and bells included) is to have it done by a highly experienced laser engineer or at least a FSE level V which by the way it would be ideal that its native language is spanish (in the case of an english to spanish translation) Service Manuals are particularly important because they are extremely technical and full of technical information covering mechanical , hidraulic and optical sciences (for example Coherent Service Manuals or User Manuals in the good old days). Even the greatest technical translator won`t be able to do the job correctly for every single aspect of engineering or medical sciences. You need a dedicated and very specific professional with years of experience in the discipline you are trying to translate and then you need a proofreader to make sure grammatical errors are properly covered.
Nowadays I don`t do that and pay some people to do it but before that, I make sure they will do a good job by asking some very technical photonics terms and asking them to tell me what does it mean in spanish or castillian (yes they use different different words describing the same). 70 % of the time the answer is wrong. What`s even worst they don`t have a clue what I`m talking about.

Keith Ensminger
Principal at Kramer Translation
Translators can earn certifications from universities, professional organizations, courts, etc., but that doesn’t necessarily guarantee they are good translators. Regulatory agencies usually mean a ‘certified translation’ has gone through the translation, edit, and review process with experienced translators–something like ISO standards. But like any standard or certification, the professional writing ability and background of your team is what produces well written translations. Our firm is not ISO certified, but we work with professional level writers, translators, editors, and reviewers.

Peter Argondizzo
Founder, Argo Translation
Thanks for the positive comment Joe.

Khaled, this is a good question, but there is no easy answer. It really depends on the company. We have been translating user documentation and software for many medical device manufacturers since 1995 and it seems that larger companies will typically source their own translation to language service providers through RFP’s while smaller companies tend to leverage their distributors. This is of course a generalization based on what I have seen over the years.

One note of caution on using distributors, when I was a project manager for a medical device manufacturer one of our distributors handled the translation of one of our user manuals and changed the name of the company in the manual. He deleted all the branding and inserted a different company name because he thought it be a better fit in the marketplace. The corporate and marketing departments were less than amused.

A good LSP or language service provider should be able to protect your branding, assist with an in-country review (this is a good place for the distributors to have some input but still allow the manufacturer to retain control) and reduce cost through the use of translation memory technology.

Glenn, makes a good point about “certified”. That word is typically always listed as a requirement with high-risk products like medical devices. There really is no such thing as “certified” translation. However most companies will consider translations created by an ISO 9001:2008 registered firm as “certified”. Another use of “certified” is if the language service provider includes a document with a sworn statement pertaining to the accuracy of the translation.

Laurice Pasciuto
Eliminating Disconnects Between Mechanical & Electrical Design Engineering | Product Design | CAD | FEA | SolidWorks
Many of our product development customers use software called 3DVIA Composer, which can not only produce documentation in multiple languages, but more cost effectively, create graphics and videos that cross language barriers. Here’s a quick intro look, let me know if you’d like more info – [http://www.solidworks.com/3DVIA_UserManuals_DOWNLOAD|leo://plh/http%3A*3*3www%2Esolidworks%2Ecom*33DVIA_UserManuals_DOWNLOAD/CfMO?_t=tracking_disc]

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
My strong recommendation for Argo Translation; I used the company for years. Tell Peter I sent you.

[http://www.linkedin.com/in/argondizzo|leo://plh/http%3A*3*3www%2Elinkedin%2Ecom*3in*3argondizzo/a_Tr?_t=tracking_disc]

Glenn Neuman
Director of Scientific Affairs at New World Regulatory Solutions, Inc.
Thank you for the clarification and detail, Khaled. I don’t get directly involved with translations, and the “certified” word floats around in regulatory circles, but I am aware that it takes some specific knowledge, and that’s why I put “certified” in quotes — so it can be defined — as you have done very well. But, does the right translation team and qualified proofreader in a specialized field still have to be “certified” for distribution in EU states or other countries?

Khaled Hamza
Business Development – Key Accounts – New Bushiness – MENA – Gulf
Hello Glenn,

Certified translators are not the key for good translation, its the quality process and choosing the translation team and the qualified proofreader with medical/engineering background and experience, having this would lead to good translations, especially in the Medical manuals field. The same goes if you are translating automotive manual so you will need relative experiences in automotive.

Certified translators mainly build their experience in legal and law related documents.

I have been working in the translation business for over 10years, I am not a translator myself, but I do the Business Development part in the Company. and we do group the translators based on their background studies and physical experience.

Michelle Bonn
President, Guideline Medical
To tie in with what Glenn mentioned, the final translation work for manuals and product packaging/labeling is typically the responsibility of the manufacturer.

Glenn Neuman
Director of Scientific Affairs at New World Regulatory Solutions, Inc.
The translations can be done by anyone, as long as they are “certified,” but it is the manufacturer’s responsibility to get it done.