ISO 13485 8.2.6
Monitoring and measurement of product
ISO 13485 8.2.6 is the clause titled “Monitoring and measurement of product” in ISO 13485, the medical device quality management standard. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 1010.2, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
What FDA writes when it cites it
The finding headings that cite ISO 13485 8.2.6 most often, as written in the letters.
- 1 letterFailure to monitor and measure the characteristics of the product to verify that product requirements have been met, as required by ISO 13485:2016 Clause 8.2.6
The standard
This is a clause reference cited in an FDA letter. Full ISO 13485:2016 text is not reproduced here. Read the standard for the complete requirements.
Cited alongside it
Regulations that appear in the same letters as ISO 13485 8.2.6.
- 21 CFR 1010.2Certification1 letter cites both
- 21 CFR 1040.20Sunlamp products and ultraviolet lamps intended for use in sunlamp products1 letter cites both
- ISO 13485 7.1Planning of product realization1 letter cites both
- ISO 13485 7.3.1General1 letter cites both
- ISO 13485 7.4.1Purchasing process1 letter cites both
- ISO 13485 7.4.2Purchasing information1 letter cites both
- ISO 13485 7.6Control of monitoring and measuring equipment1 letter cites both
Latest letters citing it
The letter citing ISO 13485 8.2.6 that FDA posted most recently.
See the letter citing ISO 13485 8.2.6 →Put this kind of reading to
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Counts include every citation in a letter, as the Letters filter does. How this database is built.