Dimando
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Instant QMS interpreter

Your QMS was meant to prevent mistakes.Instead, its complexity ensures them.

WHY

Engineers don't understand the QMS and make decisions without even looking.

You spend hours chasing them for sources. Your audit packs are built after the mistake, not before.

HOW

Dimando reads your documents and serves cited answers.

Every answer focused on what they need. Everything sourced.

WHAT

A QMS interpreter.

Every question answered. Every answer auditable.

The same problem. Every role. Every day.

The answers aren't at hand. Mistakes follow.

MedTechVerdant Medical Systems

QA Manager

Which QMS sections and records do I need to evidence for the TÜV SÜD Stage 2 audit of our CAPA and traceability process?

What it takes to answer this

2.5 hours
7 documents
3 wrong turns
Consequence

Auditor re-opens the Stage 1 finding. Second major nonconformance issued. MDR certification delayed.

Dimando's Answer

↳ 11 seconds

For Stage 2 evidence you need: CAPA-007 closure record (effectiveness check due 2025-04-15), updated VMS2-SOP-001 §5 showing RTM gate, revised VMS2-TMP-004 with RTM verification section, VMS2-TMP-RTM-001 showing the 10-column RTM structure, and QM-001 confirming 10-year retention obligation. Stage 1 finding is formally closed — the open item is the 2025-04-15 effectiveness check.

Cited Documents
VMS2-P1-CAPA-007
VMS2-SOP-001 §5
Safety Manager

Is the false negative hazard (HS-01) still under control in CardioSense AI v2.1, and what does the latest PMS data say?

What it takes to answer this

50 minutes
5 documents
2 wrong turns
Consequence

SI-2024-003 (possible false negative, stroke patient) escalates to confirmed serious incident. Field Safety Corrective Action required.

Dimando's Answer

↳ 9 seconds

HS-01 is currently controlled. Q4 2024 PMS shows 6.2% low-confidence flag rate — within the 4–8% baseline. One serious incident (SI-2024-003) involving a possible false negative in a stroke patient is still under investigation; target conclusion 2025-01-31. No field action triggered yet — monitor SI conclusion before v2.1 release decision.

Cited Documents
VMS2-P1-PMS-Q4-2024
VMS-P1-RISK-001 §2
Regulatory Affairs

What PMS data do we need to compile before submitting the CardioSense AI v2.1 MDR Periodic Safety Update Report?

What it takes to answer this

2 hours
9 documents
3 wrong turns
Consequence

PSUR submitted with incomplete adverse event summary. SI-2024-003 omitted. Notified Body requests urgent clarification, review timeline extended.

Dimando's Answer

↳ 13 seconds

PSUR must include: Q4 2024 PMS data (18,432 sessions, 6.2% low-confidence rate), SI-2024-003 investigation summary (ongoing — conclusion due 2025-01-31), complaint log (12 received, 0 confirmed serious incidents), v2.0.4 emergency patch rationale, literature surveillance signal (van der Weide 2024 — structural heart disease subgroup gap, flagged for PMCF scope update), and the current benefit-risk position confirming HS-01 remains acceptable.

Cited Documents
VMS2-P1-PMS-Q4-2024
VMS2-P1-REL-003
R&D Engineer

What must be satisfied before I can close V&V on the Clinical Review Portal feature in CardioSense AI v2.1?

What it takes to answer this

35 minutes
4 documents
2 wrong turns
Consequence

Runs all tests, misses that two new regulatory requirements (SRS-REG-018, SRS-REG-019) were added in v2.1 and are not yet in the RTM.

Dimando's Answer

↳ 8 seconds

V&V closure for CRP requires: all test cases for SRS-FUNC-052 through SRS-FUNC-071, SRS-INT-012, SRS-REG-018, and SRS-REG-019 must pass; RTM must be 100% COMPLETE for all CRP requirements; 0 open S1/S2 anomalies; and Risk Manager written approval if any S3 anomalies remain. CONDITIONAL PASS is accepted if these criteria are met.

Cited Documents
VMS2-TMP-004
VMS2-P1-REL-003
SW Engineer

I'm adding the CRP integration requirements to CardioSense AI v2.1 — what must be in the RTM before I can proceed to system testing?

What it takes to answer this

40 minutes
4 documents
2 wrong turns
Consequence

Proceeds to testing without RTM complete. Safety requirements SRS-SAFE-004, -008, -012 remain untraced. TÜV audit finding repeated.

Dimando's Answer

↳ 7 seconds

RTM must capture: SRS-ID, design output ref, TC-ID, test result, and V&V report link — all columns marked COMPLETE. Per CAPA-007, RTM completeness on safety requirements is a hard gate before Step 5 sign-off in SOP-001.

Cited Documents
VMS2-SOP-001 §5
VMS2-TMP-RTM-001
New Joiner

Where do I find the design control procedure and which templates must I use for V&V work on CardioSense AI?

What it takes to answer this

1.5 hours
6 documents
4 wrong turns
Consequence

Finds VMS2-SOP-001 after asking someone, but uses an older template version that predates CAPA-007 updates.

Dimando's Answer

↳ 6 seconds

Design controls are in VMS2-SOP-001 (8-step integrated process, Rev D). For V&V: use VMS2-TMP-003 for the system test plan, VMS2-TMP-004 for the V&V results report, and VMS2-TMP-RTM-001 for the RTM. Ensure you are on Rev B or later for TMP-003 and TMP-004 — earlier versions are missing the RTM verification section added after the TÜV audit.

Cited Documents
VMS2-SOP-001
VMS2-TMP-004

How it works

Step 1

Connect your QMS

Point Dimando at your existing QMS — PDFs, Confluence, SharePoint. Read-only. Nothing moves, nothing changes.

Step 2

Ask in plain language

Engineers ask questions the way they think them. No boolean queries. No folder navigation. No guessing.

Step 3

Get a cited answer

Every answer references the exact document, section, and revision. Auditable. Trustworthy. Instant.

Read-only architecture. Your QMS data never leaves your instance.

Before

Turn this

+ 33 more

38 documents. One question.

After

Into this

🔍

How must my MR be reviewed for a safety requirement?

SW Engineer · CardioSense AI · Step 4

Safety-tagged merge requests require approval from a peer reviewer AND the Risk Manager before merge. Coverage targets for [SAFETY] units are ≥95% statement coverage.

§VMS2-SOP-001 §7§VMS2-WI-001

↳ Found in 1.4 seconds

Try it out

No signup. No sales call. Type a question, get a cited answer from our sample QMS.

⌘ + Enter to submit

Stop losing answers that are already there.

🇨🇭Swiss partner · 15 years in the market

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Frequently Asked Questions

What is Dimando and how does it work?
Dimando is a QMS navigation tool. It connects read-only to your existing Quality Management System sources — PDFs, Confluence, SharePoint — and answers natural-language questions with citations to the exact document, section, and revision number. No migration, no data upload.
Which document formats and QMS systems does Dimando support?
Dimando connects to PDFs, Confluence spaces, SharePoint libraries, and DOORS NG repositories. Your documents remain in your existing systems. Dimando reads them — it never modifies your QMS content.
How does Dimando keep our QMS documents secure?
Dimando operates on a read-only basis. It analyzes, maps and serializes your documents in your server, your cloud or external servers. Every answer cites the exact source document and revision so your team can verify results directly. Dimando is designed for ISO 13485 and MDR-regulated environments where data integrity is non-negotiable.
Which regulatory standards does Dimando cover?
Dimando is designed for regulated industries including ISO 13485, EU MDR, FDA 21 CFR Part 820, MDSAP, IATF 16949, and ASPICE. Any QMS document your organisation uses can be connected — Dimando does not limit you to a predefined standard library.
How quickly can a team get started?
There is no migration, no re-structuring of your QMS, and no training required for engineers. The setup takes 3 to 10 business days depending on your QMS size and complexity.
What languages does Dimando support?
Dimando processes documents in the language of your QMS to deliver the highest citation accuracy. Questions and answers can be translated across major languages. Cited source documents are always returned in the original QMS language.