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.
Regulatory Compliance Articles
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.
The General Data Protection Regulation (GDPR) goes into effect in the European Union this week (on May 25). With these changes, data privacy protections are increasing substantially, as are the penalties for companies not in compliance.Linguistic Systems has been working hard to ensure that our clients, translators, and producers who hold European data are informed and ready. Here are some highlights of how the new regulations will affect our translation processes, along with other strong protections we’ve had in place for many years.
As a compliance officer, you’re under-appreciated. When compliance issues are successfully managed, you typically encounter an air of expectation and a pressure to reduce budgets. An explosion of foreign language content makes your challenge harder. Here are 7 suggestions to help you sleep better.