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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 II of this presentation, we will delve into to-market translation materials, such as website content, internal and sales training materials (including e-learning) as well as manufacturing documentation and SOPs. Finally, we will address post-market requirements, including post-market clinical follow-up (PMCF) documentation field safety notices (FSN) and regulations on medical device disposal, recycling and waste prevention.