Does the prospect of selecting a medical device translation company fill you with anxiety? The right company can do wonders for your brand, while the wrong translation company can cause major damage to both your reputation and bottom line. It’s an important decision to make, and not one to be taken lightly. These five tips will help you select a translation company that can localize your medical device materials professionally, accurately and according to local laws and regulations.
1. Do Your Research
This cannot be emphasized enough. Only look for translation companies that offer medical translations as a specialty or as their core competency. Since this area is so specialized, you should only rely on experts who understand the complicated process. Medical translators must be subject matter experts, or even doctors, who know the regulations and certifications that are required in each country.
Check references to make sure that the vendor has plenty of subject matter expertise and that it has accumulated loyal customers over the years. Also, make sure the medical translation company you’ve chosen has a dedicated project manager who is responsive and available to you as needed.
Tip: If you’re new to medical translations, you’re going to need time to understand the process. It’s OK to ask for explanations and to expect a high level of responsiveness and customer service from your vendor.
2. Look for ISO Certifications
For medical device and other medical translations, you should expect a translation company to have the following ISO certifications:
- ISO 9001:2015 – This is the international standard for quality control. It specifies general requirements for setting up a quality management system (QMS) that meets customer and regulatory requirements. This standard is intended for any organization of any size in any industry.
- ISO 17100:2015 – This standard is similar to ISO 9001, but it’s geared towards the specific processes required to deliver quality translation services.
- ISO 13485:2016 – This standard outlines specific quality management system requirements for companies providing medical devices and related services.
Tip: If a medical device manufacturer outsources its translations, the manufacturer will be held accountable for the work of the translation company. That’s why many medical device companies require translation vendors to obtain the ISO 13485 certification.
3. Gather Bids
When you’re researching a medical device translation vendor, it’s a good idea to seek a few different bids. This does not have to be a formal RFP process, but it’s important to make sure you are comparing apples to apples. For example, when speaking to different translation companies, make sure you provide clear and consistent project instructions and then ask for a full explanation of how the vendor will complete the required tasks, how long it will take to do so, and what the cost for services will be.
It’s especially important to understand the vendor’s quality management system. If a vendor only has one quality control step, ask why. At Morningside, our quality assurance process includes multiple rounds of editing and proofing with built-in redundancies to ensure accuracy, proper terminology, and correct localization for the target audience.
4. Don’t Expect Cheap and Fast Translations
Have you heard of the project management triangle? It’s a concept that’s been around since the 1950s. In this model, there are three key elements – good, fast and cheap. Your project can be any two of these – but it’s impossible to achieve all three.
With medical device translations, the work must be good – there is simply no room for inaccuracy in this industry. If you cut corners to save money and time in the short term, you will pay for it later (products will be pulled from shelves and costly litigation can take place).
That leaves you with a choice to make about cost. If you want your project completed quickly, it’s not going to be cheap. Rush fees will be applied. However, you can save money (and avoid rush fees entirely) if you plan a project timeline with your vendor well in advance of your deadline.
5. Talk to Fellow Industry Professionals
Are you in touch with fellow medical device colleagues at other companies? Are you attending an industry trade show in the near future? Try asking fellow professionals which translation vendor they’re using and whether they’ve learned any helpful lessons along the way. It’s always better to learn from others than to experience issues first-hand.
Invitation to Connect
If you’d like more information about medical device translations, feel free to reach out to us today or request a complimentary quote. As a medical device translation company, we have all three ISO certifications and 20 years of industry experience.