Find out when your documents stop agreeing.
Sahayog reads your design history, risk file and labeling, finds where they contradict each other, and traces each change to the documents it affects. You can correct them before an audit.
Built by Sahayog Labs for medical device teams working to FDA and EU MDR. Upload your files to start. SharePoint and Google Drive connections are coming soon.
Sahayog running on a sample technical file of 12 PDFs.
See it work.
Captured from the product, using the technical file of a fictional glucose monitor.
1
Bring in your documents, and choose how AI is used
Upload your controlled documents, see exactly which AI model would read them, and invite your team with roles.
2
Before you change a part, see what it reaches
Name a part that is being replaced or discontinued, and see every requirement, hazard, test and document connected to it.
3
From an NCMR or complaint to the hazards it touches
Paste an NCMR, complaint or CAPA to find the matching hazards in your risk file, with their ratings and controls.
4
Each change, traced to what it affects
An approved change shows everything it touches, and which documents still describe the old design.
5
Press one button, and the update is drafted for you
Sahayog writes the redline from your own documents, cites every change, and nothing is updated until you approve it.
6
Ask, and see where the answer came from
Answers come from your documents only, and every statement links to the passage behind it.
7
Who changed a document, why, and what changed
Each revision shows who signed it, the change request behind it, and the wording that changed.
8
Drafts follow your house style
Drafts follow the numbering, control blocks and terminology of your approved documents.
9
Traceability you don’t maintain by hand
Each requirement with its part, test, risks and changes, with every gap marked.
10
A record of every action
Checks, decisions, drafts and uploads are logged with who and when, and entries cannot be edited or removed.
Your technical file, checked every night.
A technical file is hundreds of documents that have to agree. When one changes, others fall out of date. Sahayog shows you which ones.
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1
Bring your documents
Upload them. SharePoint and Google Drive connections are coming. Sahayog extracts your requirements, risks, tests and claims, and how they link.
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2
It checks every claim against its evidence
Each night it compares your documents with each other and lists what disagrees, and where.
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3
Draft the correction
Pick how to resolve it. Sahayog drafts the edit with citations, sends it to the document’s owner, and records who approved what.
The kind of thing it catches.
A labeling claim with nothing behind it
The IFU says 14 days; verification tested 10.
A change that never reached the risk file
The adhesive supplier changed in May. Hazard H-14 still cites the old material.
A requirement no test verifies
Alert latency is specified in SR-31, but no test traces to it.
Documents citing different revisions
The DHF cites spec rev B; the current spec is rev D.
Built for regulated work.
Each company’s data is separate
Each company’s documents are isolated at the database level. Other accounts cannot reach them.
AI is off until you turn it on
Checks that need AI stay off until an admin enables them. Every drafted sentence cites the document it came from.
A tamper-evident record
Every finding, edit and approval is written to a log that cannot be altered without detection. It shows who changed what, and when.
Questions.
What is Sahayog?
Sahayog is software that checks a medical device technical file or design history file (DHF) for contradictions between documents. It traces each change to the documents it affects and drafts the correction for the document owner to approve. It is in private beta, by invitation.
How does Sahayog find inconsistencies in a technical file or DHF?
It reads your documents, recognises the requirement, risk, test report and change request IDs in them, and checks the documents against each other with rules for FDA design controls and EU MDR technical documentation. Each finding quotes the exact sentences from the source documents as evidence. Superseded revisions are not flagged.
Which file types can Sahayog read?
PDF, Word (.docx), Excel (.xlsx), Markdown and plain text. PDFs need a text layer, so run OCR on scanned PDFs first. Upload files in the browser. Google Drive and SharePoint/OneDrive sync is coming soon.
Does Sahayog work with our own document numbering?
Yes. It recognises common requirement, risk/hazard, test report and change request IDs out of the box, such as REQ-, SRS-, RISK-, HAZ-, TR-, DVR-, CR- and ECO-. Each company can also add its own ID prefixes.
Which FDA and EU MDR requirements does Sahayog check?
For FDA design controls, it flags stale or missing verification, risk controls with no verification, approved changes not carried through to the affected documents, documents that cite things dated after their own effective date, and contradictions between current documents. For EU MDR technical documentation, it checks coverage of the Annex II sections, the GSPR, clinical evaluation and post-market surveillance.
Is AI required, and which model sees our documents?
No, AI is optional and off by default. The consistency checks run without AI. If a company admin turns AI on, the admin can see which model provider is used.
How is our data kept separate, and can it be deleted?
Each company’s data is isolated by row-level security in the database, so other companies cannot reach it. A company’s data can be deleted on request by emailing shreyas@sahayog.org.
Does Sahayog replace our QMS or regulatory review?
No. Sahayog flags issues with quoted evidence and drafts corrections, and the document owner approves each one. Engineers acknowledge or dismiss each finding with a reason, and that triage is kept across re-runs. Every action is recorded in a tamper-evident audit trail.
What else does Sahayog do besides consistency checks?
It runs impact analysis before you change a part, and matches an NCMR, complaint or CAPA to the hazards it touches. It builds a trace matrix from your documents, and Ask answers questions only from your company’s documents, with cited quotes. It also drafts in your house style and exports a DOCX gap report.
How do I get access to Sahayog?
Sahayog is in private beta and access is by invitation. Email shreyas@sahayog.org to ask for an invite.
Start with one product’s technical file.
Private beta, by invitation. Setup takes a few minutes once you’re in.