Medical Devices Translation Life Cycle II: To-Market and Post-Market Regulatory Requirements
Course summary
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 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. Training program: - The to-market and post-market medical device lifecycles - Internal vs. external communications and requirements - Training materials for a digital world - Understanding new waste, recycling and disposal requirements and language - Translation resources - Terminology strategies Translators who were interested in this training were also interested in Where Regulatory Rules: Translating Drug Leaflets, Packaging and Labelling Online training SOAP Notes and Medical Charts: The Nitty Gritty of Medical Reports Online training Medical Devices Translation Life Cycle II: To-Market and Post-Market Regulatory Requirements Online training 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 identify the requirements for to-market translation materials. To understand regulatory requirements and controlled languages for internal and external documentation. To identify glossaries and language resources for translating post-market documentation.. To develop a system for managing controlled language and flagging regulatory requirements in TMs. Prerequisites No prerequisites. Program Click to expand - The to-market and post-market medical device lifecycles - Internal vs. external communications and requirements - Training materials for a digital world - Understanding new waste, recycling and disposal requirements and language - Translation resources - Terminology strategies Registration and payment information (click to expand) Click to expand Price: 25.00 USD Click on the buy button on the right to purchase your seat Participation fee includes unlimited access to the recording and handouts provided by the trainer. How do I purchase the video? To purchase your seat at this session please click on the "buy" button. After your payment is received, your status will be changed to “registered and paid” and an invoice and receipt of payment will be sent to you for your records. How do I access the video? Once the payment is processed you will be able to watch the video here. Where can I find a certificate of attendance? 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 Created by Erin Lyons View feedback | View all courses
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