Alignment Dashboard
Founding Member Access

Your Devices

Each device is its own project with a full set of design controls under your shared QMS.

Active projects
2
Across 1 QMS
Open design controls
14
Across all projects
QMS health
Good
No critical gaps
Design Phase
CardioSync Pro
Class II Implantable Cardiac Monitor · 21 CFR 870
Clarity Hub
40%
Risk Radar
25%
Change Stream
10%
Planning
NovaBand SW
SaMD Companion App · IEC 62304 / FDA SaMD Guidance
Clarity Hub
8%
Risk Radar
0%
Change Stream
0%
Add another device project
QMS-Wide modules are shared across all projects
Process Library, Team & Training, Learning Center, and Audit Ready apply to your entire organization — not just one device. Find them in the sidebar under QMS-Wide.
You're a Founding Member

Tangram eQMS is actively being built.

You have early access to the platform as it takes shape. Modules will unlock progressively over the coming weeks. Your feedback directly shapes what we build next — reach out anytime.

9
Modules Planned
Alignment Dashboard
Daily quality health view with open questions, risk alerts, and phase gate status.
In progress · skeleton live
Clarity Hub
User needs → design inputs → outputs with enforced traceability. Heart of 21 CFR 820.30.
Coming next
Risk Radar
Living ISO 14971 risk management from concept stage. Hazard library, heat map, benefit-risk.
Planned
Change Stream
Log changes in seconds. AI traces impact and assigns change level proportionally.
Planned
V&V Module
Hardware and software V&V built in. Test protocols, manufacturing validation (IQ/OQ/PQ), and SaMD verification.
Planned
Process Library
SOPs with the "why" embedded. Regulatory reasoning in plain language, not just the form.
Planned
Learning Center
Role-based quality education with foundational tracks and embedded micro-lessons.
Planned
Team & Training
Competency tracking, training matrix, and 21 CFR Part 11 training records.
Planned
Audit Ready
DHF completeness index, e-signatures, and one-click regulatory export.
Planned
Build Roadmap
Landing page & early access Live
Marketing site, auth flow, founding member access
Clarity Hub Building
User needs, design inputs, traceability matrix
Risk Radar Next
Hazard identification, risk estimation, control tracking
Change Stream + V&V Planned
Lightweight change log with AI impact assessment
Learning Center + Process Library Planned
Education-first SOPs and role-based learning tracks
You're building with us

As a founding member, you have direct access to Eric Sugalski and the Tangram team. We're building this platform with active feedback from early users like you.

Tell us what you need most. Which module should we build first? What pain point is most acute for your team right now? Your input shapes the product.

Reach out to Eric