How to Design a Translation Workflow Compliant with MDR and ISO 13485 in 5 Steps
Regulatory and Quality leaders in the medical device industry face a significant challenge: meeting the demanding linguistic requirements of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) ahead of their respective 2028 and 2027 deadlines. This means translating documentation into as
Using AI for Translation: Stay MDR-Compliant
Are you using Machine Translation or AI to translate medical device documentation? Wondering whether that could lead to non-compliance with Regulation (EU) 2017/745 (MDR)? Here’s what you need to know.
The importance of ISO 17100 when choosing a translation partner
Choosing a translation partner can be a challenging undertaking. You want a partner with an established quality assurance process, expertise in the languages you need, strong data security protocols, a responsive project management team, and last but not least a company that can meet your
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How to Design a Translation Workflow Compliant with MDR and ISO 13485 in 5 Steps
Regulatory and Quality leaders in the medical device industry face a significant challenge: meeting the demanding linguistic requirements of the Medical Device Regulation (MDR) and
