The video provided below shows you exactly what you will receive when you purchase our labeling procedure (SYS-030) and associated forms.
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:
- SYS-030 A, Labeling Procedure
- FRM-033 A, EU MDR Regulation EU 2017-745 Labeling Requirements Checklist
- FRM-036 A, FDA and CMDR Labeling Requirements Checklist
- TMP-006 A, IFU Template
- TMP-007 A, Label Template
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.
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.
About the Author
Robert 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. Robert 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 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’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 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.