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

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.


Training program:

- What is a medical device?
- Types of pre-market documentation
- Translating pre-market regulatory correspondence
- Regulatory language and templates
- Translation resources
- Terminology strategies





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Medical Devices Translation Life Cycle II: To-Market and Post-Market Regulatory Requirements
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Translators already specialising in medical translation.
Translators considering crossing over into medical translation.
Translators who want to learn more about translating for the medical devices sector.

At the end of this session, participants will be able:

To understand the expanded definitions of medical devices.

To identify language-specific resources to ensure compliance with the expanded regulatory framework.

To identify the documents and templates that are part of the pre-market medical device lifecycle.

To develop strategies to manage terminology for multiple platforms (physician-facing, patient-facing, software/device input, online tutorials, etc.).

No prerequisites.

- What is a medical device?
- Types of pre-market documentation
- Translating pre-market regulatory correspondence
- Regulatory language and templates
- Translation resources
- Terminology strategies

Price: 25.00 USD
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A certificate of attendance can be issued upon training completion and as per your request. A certificate of attendance can be downloaded at http://www.proz.com/profile/?show_mode=standard#trainings

 Erin Lyons    View feedback | View all courses

Bio: 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).