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

Formats: Webinar presentations
Topics: Translation quality assurance
Terminology management
Medical translation

Course summary
Start time:Sep 28 14:00 GMT     Add to calendar

Duration: 60 minutes.

Check what time the course is running in your local time here.

The webinar can be purchased individually, but if you wish to participate in all sessions from the bundle you might wish to purchase two online sessions as a complete package at a special price. Purchase two online sessions for only 60 USD 44 USD today!

See other sessions from the bundle below:

* September 28 Medical Devices Translation Life Cycle I: Pre-Market and Regulatory Requirements

* October 19 Medical Devices Translation Life Cycle II: To-Market and Post-Market Regulatory Requirements




Your purchase includes:

* access to the online session with a Q&A portion,
* unlimited access to video recording and handouts (available within one working week after the session),
* a certificate of attendance available for download from your ProZ.com profile.

Important: Those who purchase a seat in advance may be able to pay an "early bird" or cheaper price, while those who confirm participation later or last minute, may likely have to pay a higher fee. In some training sessions a price increase based on the number of registrants may also apply, i.e. the first 15 registered pay one price, the next 10 pay a a slightly higher price etc.

Early payment is advised in order to secure participation and help reach the course minimum participation - unfortunately, courses may occasionally be cancelled or rescheduled, if the confirmed participation in advance is very low.

Even if you do not attend the online session you will still have unlimited access to the video recording and training materials within one working week after the session.

Useful links:
Once uploaded, the video will be available from the video centre
ProZ.com training cancelation policy.
Language:English
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.

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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Target audience
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.
Learning objectives
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.).
Prerequisites
No prerequisites.
Program
Click to expand
- What is a medical device?
- Types of pre-market documentation
- Translating pre-market regulatory correspondence
- Regulatory language and templates
- Translation resources
- Terminology strategies
Virtual platform system requirements
Click to expand
For PC-based Users:

• Required: Windows 7 – Windows 10
• Required: Google Chrome v39 or later; Mozilla Firefox v34 or later; Internet Explorer v8 or later (JavaScript™ and Java™ enabled)
• 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

• Operating system: Android 4.0 (Ice Cream Sandwich) or later
• Internet connection: 3G connection or better (WiFi recommended for VoIP audio)
• Software: Free GoToWebinar App from the Google Play Store

Recommendations

• For the visual section of the training course, we recommend that you have a 64kbps link. This means using an ISDN line or Broadband. Wireless connection is NOT recommended.
• For the audio section of the training course, we recommend that you have a headset or speakers.
• We recommend that you log in 30 minutes in advance of the start time to prepare for the training course.

Courses will be open half an hour before the start time. Please login before the start time to ensure that everything on your system is working correctly.
Registration and payment information (click to expand)
Click to expand
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.
Trainer
 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).
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Attendees (6)
Course limit: 20
Federica Cuneo
Registered and paid
Melissina
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Fabienne G PERROT
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Luisa Antunes
Registered
Isadora Veiga
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cloudhunter
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 dalin20
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Dr. KareemAddin Maklad
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