This procedure is intended to meet the requirement for a recall procedure in accordance with ISO 13485:2016, Clause 8.3.3 and 21 CFR 806.
This 7-page recall procedure meets the requirements for clause 8.3.3 of ISO 13485:2016 and 21 CFR 806 for conducting corrections and removals of product. This procedure was recently updated to include references to the applicable ISO 13485:2016 clauses, and color-coding was added by Matthew Walker to facilitate auditors identifying where the requirements for each sub-clause are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process. This updated procedure also meets the requirements for an advisory notices procedure.
This procedure is applicable to the following medical device markets: 1) USA, 2) Canada, and 3) Europe. There is a separate section specific to each medical device market.
One of the most common causes of recalls is mix-ups in labeling. Therefore, if you are interested in learning more about recalls and labeling, please see our webinar on recalls, labeling, and 21 CFR 820.120.
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.
SYS-020 Recalls & Advisory Notices Procedure
To view all available procedures click here
To review a sample Medical Device Academy procedure click below: