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

To purchase your seat at this session please click on the "buy" button. Available slots are limited and will be assigned to registered and paid participants as soon as payment is reported. Early payment is advised in order to secure participation. Allow some time for payment processing if you are paying by wire transfer.

After your payment is received, your status will be changed to “registered and paid” and your spot for the session will be secured. An invoice and receipt of payment will be sent to you for your records.

How do I access the online platform?

72 hours before the webinar takes place, you will receive an invitation to join the session. Please, click the registration link or button provided in the invitation email and complete the registration form.

For PC-based Users:

• Required: Windows 7 – Windows 10
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• Required software: GoToWebinar desktop app; JavaScript enabled
• NOT required: Microphone - attendees can communicate with the trainer through incorporated chat.

• Internet Connection Required: 1 Mbps or better (broadband recommended)
• Recommended: 2GB or more of RAM (recommended)


For Mac®-based Users:

• Mac OS X 10.8 (Mountain Lion) – 10.11 (El Capitan)
• Required: Microsoft Edge; Apple Safari v6 or later
• Required software: GoToWebinar desktop app; JavaScript enabled
• NOT required: Microphone - attendees can communicate with the trainer through incorporated chat.

• Internet Connection Required: 1 Mbps or better (broadband recommended)
• Recommended: 2GB or more of RAM (recommended)

Join from Android

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• For the audio section of the training course, we recommend that you have a headset or speakers.
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 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).