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Medical device translation not only requires expert medical and linguistic knowledge, but also an understanding of the strict industry standards and regulatory framework. In a sector that is undergoing constant technological advancements, even the definition of a “medical device” continues to expand – now even including software, in vitro reagents and tissue engineered medical products.
In part I of this presentation, we will take a closer look at translation requirements for pre-market documents, including the content of pre-market submissions, regulatory clearance requirements and the compendium of approval documentation. We will also examine the main regulatory standards for medical devices and some more recent updates to requirements for device traceability, disposal and non-traditional medical devices.