If you work at a medical device company, you know that having accurate translations for your medical device content, such as medical device packaging, product labeling, instructions for use and marketing materials, is essential. But with so many different translation companies out there, how do you choose the right one? In this blog post, we’ll discuss some of the key factors to consider when selecting the right medical device translation company for your business’s needs.
A Defensible Process
Risk management is essential to compliance-intensive industries like yours. Incorrectly translated medical device content can lead to injuries and lawsuits, and jeopardize a company’s reputation.
A good medical device translation company will be a partner in helping you to manage these risks. They will have a rigorous, documented workflow for each translation project they undertake as part of their commitment to a defensible process. Does the medical device translation company you’re considering have one?
Certification for ISO 13485
ISO 13485 certification is the global quality standard for medical device-related services. Companies that achieve this certification demonstrate their commitment to quality and safety standards, and can assure customers that the services they receive will be compliant with relevant regulations.
For medical device translation companies, ISO 13485 certification sets a benchmark to follow for quality, consistency and customer satisfaction. To ensure your content is translated right, it’s important to choose a medical device translation company that is certified for ISO 13485. Not to mention, sometimes that’s a compliance requirement.
Breadth of Service, Depth of Knowledge
When your medical device content needs to be translated into multiple languages and localized for markets overseas, the translation company you choose should bring both breadth of service and depth of knowledge to the table.
Their services should be available in all of the language pairs you need, including any specific dialects that may be required, and any linguists who work on your project should not only have excellent linguistic skills in both the source and target languages, but years, if not decades, of subject matter expertise, including specific terminology, regulations and practices, and safety protocols.
In addition, a good medical device translation company will allow you to be involved in the final team selection process, if you wish to be involved. Does the medical device translation company you’re considering let you do that?
Ability to Meet Additional Compliance Requirements
As compliance requirements continue to evolve in different markets, the ability to meet additional requirements is essential, including any related to translation. A good medical device translation company knows this, is easy to work with and is committed to working with you to ensure that any and all additional compliance requirements will be met.
Your Partner for Accurate Medical Device Translation
Certified for ISO 13485, Responsive Translation has been providing high-stakes translation to compliance-intensive industries like yours for more than 30 years. For more information about how we can help you, please get in touch at 646-847-3309 or [email protected].