ISO 13485 7.1
Planning of product realization
ISO 13485 7.1 is the clause titled “Planning of product realization” in ISO 13485, the medical device quality management standard. Since 2021, 5 FDA warning letters have cited it.
- Letters citing it
- 5 since 2021
- Jan 1 to Oct 30, 2026
- 5 against 0 on the same dates in 2025
- Most often cited with
- ISO 13485 7.3.9, in 3 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 52026
What FDA writes when it cites it
The finding headings that cite ISO 13485 7.1 most often, as written in the letters.
- 3 lettersFailure to document one or more processes for risk management in product realization, as required by ISO 13485:2016, Clause 7.1
- 1 letterFailure to document one or more processes for risk management in product realization and determine, as appropriate, quality objectives and requirements for the product, as required by ISO 13485:2016 Clause 7.1
- 1 letterFailure to establish, implement, and maintain one or more processes for risk management in product realization, as required by ISO 13485:2016 Clause 7.1
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 7.1.
- ISO 13485 7.3.9Control of design and development changes3 letters cite both
- ISO 13485 7.4.1Purchasing process3 letters cite both
- ISO 13485 7.6Control of monitoring and measuring equipment3 letters cite both
- ISO 13485 8.5.2Corrective action3 letters cite both
- ISO 13485 7.3.1General2 letters cite both
- 21 CFR 1010.2Certification1 letter cites both
- 21 CFR 1040.20Sunlamp products and ultraviolet lamps intended for use in sunlamp products1 letter cites both
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
Latest letters citing it
The 3 letters citing ISO 13485 7.1 that FDA posted most recently.
- DevicesView Unilam Co., LTDSUV 600-800/KT/GYU UV SunlampIssuedSep 22, 2026PostedOct 6, 2026
- DevicesView Lion Street Medical, d/b/a Pensar Medical LLCWoundPro Negative Pressure Wound Therapy (NPWT) System, WoundPro+ NPWT System, and MicroDoc (PocketDoc) Portable NPWT SystemIssuedAug 21, 2026PostedSep 22, 2026
- DevicesView Nipro Renal Solutions USA, CorporationDry and liquid hemodialysis dialysate concentrate solutionsIssuedJul 24, 2026PostedAug 18, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.