Update your SOPs to current regulations and standards, as Word tracked changes
Upload your own Word procedures. The SOP Revision Service finds Quality System Regulation wording, old 21 CFR 820 section references, and outdated editions of the ISO, IEC, EU, MDSAP and national references your procedures cite. It returns your files with every edit as a Word tracked change, plus a change report that explains each one. Your format, headings, headers, footers, roles and process stay as they are.
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Free preview first. See how many changes we found, and a few of them in full, before you pay.
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Express, usually ready within an hour, depending on the length of your procedures and how many you send, or Expert Reviewed by Aaron Lyon, former Director of Quality Assurance and International Regulatory, within 2 business days.
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You stay in control. Nothing is accepted for you. You accept or reject each change in Word and release the documents under your own document control.
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Your files are deleted after 7 days and never used to train AI models. See How we handle your documents, below.
What the medical device change pack updates
Former 21 CFR 820 section citations (for example 820.100, 820.30(j), 820.198) to the ISO 13485:2016 clauses the QMSR incorporates, adding 21 CFR 820.10, 820.35 or 820.45 where FDA keeps its own requirement.
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"Quality System Regulation" and "QSR" to "Quality Management System Regulation" and "QMSR".
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"Management with executive responsibility" to "top management".
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Design History File, Device Master Record and Device History Record: keep your terms and link them once to the ISO 13485 names, or switch to the ISO 13485 names. Your choice.
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Outdated standard editions, for example ISO 14971:2007 to ISO 14971:2019, ISO 10993-1:2009 to ISO 10993-1:2025, ISO 9001:2015 to ISO 9001:2026, and 40 more. Where a new edition changed requirements, the change report tells you which sections to check.
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Replaced regulations and documents, for example the EU Medical Device Directive to the EU MDR, ANVISA RDC 16/2013 to RDC 665/2022, IEC 62366:2007 to IEC 62366-1:2015, and the current MDSAP audit approach version.
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Flags, without changing: statements that management review or audit reports are withheld from FDA (the QMSR removed that exception), renumbered 820.3 definitions, and anything that needs your company's decision.
Headings, headers, footers and document structure are never changed. Revision history tables are never edited, because past entries are historical records.
Requirement updates: a library of 17 standards and regulations
What we add to your procedures
We also bring the procedure itself up to date. Where a revised standard or regulation now requires something your SOP does not yet say, we draft the missing steps in your SOP's own style, as tracked changes, and the change report cites the clause. These requirement updates cover a library of 17 standards and regulations that we keep current: FDA QMSR (21 CFR 820), 21 CFR 803, 806, 830 and 801 (UDI) and Part 11; ISO 13485, ISO 14971, ISO 9001:2026, ISO 14155, ISO 10993-1, ISO 11135, ISO 11137, ISO 11607 and ISO 14644; IEC 62304 and IEC 62366-1; and the EU MDR. Requirements outside a procedure's subject are skipped.
Is this a proofreading service?
No. We correct obvious errors in edition years and flag other errors we notice, but we do not check spelling, grammar or clause numbers.
Which quality systems are covered?
Coverage is for medical device quality systems (QMSR, ISO 13485, MDSAP and related standards). ISO 9001, food safety and HACCP change packs are coming.
What does it cost?
Express: $49 per document, $295 for up to 10, $695 for up to 30. Expert Reviewed: $149 per document, $795 for up to 10, $1,895 for up to 30. You always pay the lowest price for your number of files. You are not charged for any document that comes back with no changes: we refund it automatically.
Accuracy guarantee
If a file is damaged or a change misstates a requirement, we correct it within 2 business days or refund that document. You can ask within 14 days of delivery. The full terms are in our Terms and Conditions.
How we handle your documents
What we keep: the Word files you upload, the revised files and the change reports. Nothing else from your files.
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How long: unpaid uploads are deleted after 24 hours. Paid orders are deleted automatically 7 days after delivery. You can delete everything sooner with "Delete my files now" on your order page.
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Who sees them: for Express orders, no person reads your files. For Expert Reviewed orders, only Aaron Lyon opens them, under the confidentiality commitment in our Terms.
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AI processing: your text is processed by Anthropic's Claude through its commercial API, which does not use customer content to train its models.
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Storage: files are stored encrypted on Cloudflare's network with private, unguessable order links. They are never published or added to the website.
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Payments: Stripe processes your card. We never see or store card details.