The video provided below shows you exactly what you will receive when you purchase our labeling and translation procedure (SYS-030).
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 & Translation Procedure
- FRM-033 A, New EU MDR Labeling Requirements Checklist
- FRM-036 A, M5 MDD 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.
SYS-030, Labeling & Translation Procedure; This training includes our procedure, form and templates for labeling. You will also receive a link to download our slide deck and webinar recording on recalls and labeling, because labeling mix-ups are the #1 cause of recalls.
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.