Recall Procedure & Advisory Notices Procedure (SYS-020)

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.

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The recall procedure is now in its fifth draft of the procedure. The recall procedure meets the requirements for clause 8.3.3 of ISO 13485:2016 and 21 CFR 806 for conducting corrections and removals of products. This updated procedure also meets the requirements for an advisory notices procedure. Matthew Walker updated the procedure to include references to the applicable ISO 13485:2016 clauses, and he added color-coding with symbols to auditors identifying where the requirements for each ISO 13485 requirement are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process.

This procedure is applicable to the following medical device markets:

  1. the USA,
    • 21 CFR 7 – FDA Enforcement Policy
    • 21 CFR 806 – FDA Corrections and Removals
  2. Canada
    • SOR 98/282, Sections 63-65 – Recalls
    • Health Canada Guidance to Recall of Medical Devices (GUI-0054)
  3. Europe
    • MEDDEV 2.12/1 – Guidelines on Medical Devices Vigilance System
      • Field Safety Corrective Action (FSCA)
      • Field Safety Notice (FSN) Template
    • Regulation (EU) 2017/745

There is a separate section specific to each medical device market. As with all of our procedures, you will receive access to free updates of the procedure with your original purchase. The procedure now includes the following content:

  • FRM-020 A D1 Complaint Record
  • FRM-052 A D1 Recall Report
  • SYS-020 A D5 Recalls & Advisory Notice

The two most common causes of recalls are mix-ups in labeling and failure to properly validate software updates. If you are interested in learning more about recalls and labeling, please see our webinar on recalls, labeling, and 21 CFR 820.120. If you would like to learn more about software validation, please consider purchasing our software validation procedure (SYS-044).

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. 

Recalls Advisory Notices Procedure Recall Procedure & Advisory Notices Procedure (SYS 020)
SYS-020 Recalls & Advisory Notices Procedure
SYS-020 Recalls & Advisory Notices Procedure
Price: $299.00

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