What are the medical device translation requirements you need to know? Introducing a new product or an update to an existing product comes with a unique set of compliance regulations in each jurisdiction. Being prepared for this with a competent, repeatable process is key. This article highlights the challenges and requirements you’re likely to face.
As a medical device manufacturer, your organization faces challenges that companies in other industries may not face, especially when it comes to the closely related areas of patient safety and regulatory compliance. But expanding beyond your home country requires that your medical device translation procedures must meet the same high standards as preparing documentation in your original language. Optimizing your medical device translation workflow for speed, accuracy, and compliance is necessary to help ensure leadership in the medical device space. This article highlights how to do that.
For medical devices to fulfill their important roles safeguarding patients’ health, medical professionals and individual users must understand how to operate them. But what if the people using the devices aren’t native speakers of the device manufacturers’ printed instructions? This highlights the profound importance of medical device translation and the need to ensure accuracy, regulatory compliance, and local understanding as part of the process. This article highlights how to integrate best practices as part of the medical device translation process.
Foreign language interpreters can be a blessing in trauma therapy situations where children, immigrants, or other non-natives are at a disadvantage by not knowing the therapist’s first language. However, interpreters who do not understand psychotherapy or their role can inadvertently step on the process. Here’s what to watch out for when using interpreters for therapy.
For medical and pharmaceutical clients, back translations are necessary facts of life; they are absolute requirements for most clinical research documents that must be translated into other languages. But for experienced professional translators and editors who work in this area, back translations seem a wrongheaded way to approach accuracy and faithfulness to the source document. What is the right way to go?
