February 28, 2018 - 2:00 PM
February 28, 2018 - 3:00 PM
Writing for the Medical Device Regulated Industry
The Medical Device industry is responsible for the development, manufacture and distribution of medical devices used in all medical settings. Examples of medical devices can range from band aids and tongue depressors, to radiation equipment for cancer treatments and implantable heart devices such as pacemakers. In the United States, Medical Devices are placed into categories, or Classifications. These classifications determine the risk and quality controls needed to create and distribute the device. As part of this classification, the labeling requirements are also outlined. All medical devices, regardless of classification, require instructions for use, or labeling. Labeling is typically created by a combination of technical writers, regulatory specialists, engineers and manufacturing personnel. This is becoming a niche area for technical writers, especially those who know and understand the regulations that govern the labeling requirements.
This webinar is an introductory session for writers who are new to or want to work in the medical device industry. You will learn:
- The definition of labeling
- Classifications of medical devices and the impact on labeling
- The regulations that govern medical devices in the US, Canada, EU, Japan and China
- How to interpret the regulations
- The impact of regulatory submissions on labeling
- How to balance good writing practices and regulations
Frequently Asked Questions
When do education events take place?
Webinars are held every Wednesday afternoon from 2-3 PM EDT/EST (GMT-4/5).
A majority of online courses are held Tuesdays-Thursdays between 10:00 AM-1:00 PM EDT/EST (GMT-4/5), as to not conflict with webinar times.
When will I receive the GoTo Webinar instructions for an event?
Registered attendees will receive the GoTo Webinar instructions three (3) hours before the webinar begins, approximately at 11:00 AM EDT/EST.
Registered attendees will receive the GoTo Webinar instructions one (1) day before the online course begins.
To participate in a webinar and an online course, you must be able to access GoTo Webinar, STC’s online meeting space. GoTo Webinar is a standard web seminar tool (no separate download required) and all you need is a reliable Internet connection and phone line, or a computer with VoIP capabilities.
I registered for an online course, what are my next steps?
Once you register for an online course, you will receive a confirmation receipt that day. A majority of our online courses uses Moodle, STC’s course management site, which attendees will receive the login instructions two (2) days before the course begins.
If you cannot access Adobe Connect and/or Moodle (as needed), then you will not be able to successfully complete an online course.
I registered for a webinar, but will be unable to attend. Will a recording be available?
If a registered attendee is unable to attend a webinar that day, they will receive an email with a link to the recording, and an evaluation link along with the PDF of the presentation.
I registered for a webinar and/or an online course, but cannot attend at that time. Will I receive a refund?
If a registered attendee is unable to attend a webinar and/or an online course, the cost is transferable to a future event, but is not refundable. Online registration closes one-two business days before the education event begins.
I want to take a specific course that isn't listed online. Will it be offered in the future?
STC rotates its courses every year as we try to offer the most popular ones within the first half of the year. Online courses are subject to change or are offered more than once per quarter. If a course is not listed, STC will offer it again in the following year.
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