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Medical Devices Translation Life Cycle I: Pre-Market and Regulatory Requirements

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Duration

58 minutes

Description

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.
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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.

Upload Date

October 02, 2017

Trainer Bio

Erin Lyons - Erin M. Lyons is a full-time French to English and Italian to English translator, medical writer, and consultant and the Owner and President of BiomedNouvelle. Her primary areas of focus include clinical research, pharmaceuticals, medical devices, and cosmetic products and she has split her professional career between Europe and the U.S. She has a BA in Romance Languages and Literature from the University of Chicago and an MA in Italian and French Translation from the Monterey Institute of International Studies. She has presented at several ATA Annual Conferences, as well as at the 2011 World Congress of the International Federation of Translators and the 2013 ProZ.com International Conference (Porto) and 6th Annual Congress and Training in France (Biarritz).

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