Join our live webinar on November 25 to discover how to effectively review, edit, and implement Medical Device Academy’s labeling procedure.
When is the live webinar scheduled for the Labeling Procedure?
The live webinar is scheduled for Monday, November 25, 2024 @ 10:30 a.m. ET. If you purchased the procedure before November 25, you will receive login information to participate in the live webinar. The webinar will be hosted on Streamyard.com. If you are unable to participate in the live webinar, please send us your questions in advance so that we can be sure to address your questions in the live webinar. You can download the recording from the Dropbox folder after the live webinar and watch it as many times as needed.
Labeling checklist forms and labeling templates are included with the procedure. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
We are also including a training webinar on labeling and recalls, because labeling mix-ups are one of the most common reasons for medical device recalls. The FDA website also provides information about the medical device labeling requirements. The webinar also covers instructions for use, which is considered part of labeling.
After March 3, this procedure will no longer include Translation and that area will be covered under a new Translation Procedure (SYS-052).
If you have specific questions about device labeling, or MDR compliance, please use our calendly app to schedule a call with a member from our team.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.
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About Your Author
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Instagram.