Most medical device founders treat quality as a compliance tax. The ones who win treat it as their first strategic tool. Tangram eQMS is the only platform that teaches you quality before asking you to document it.
"When should I get started with quality?"
Before your first prototype. Quality isn't a Phase 3 checkbox — it's a design compass. Build it in from day one and it accelerates development; bolt it on at the end and it derails it. The companies that win build quality into their design process from the first sketch.
"Is this going to overwhelm my team?"
Not here. Every form in Tangram eQMS comes with the explanation behind it. We teach you why each requirement exists before asking you to fulfill it. This isn't a document factory — it's a quality education platform. The paperwork is the byproduct, not the goal.
"What's this going to cost us?"
Nothing — during our founding period. Tangram eQMS is completely free for early-access members. We believe cost should never be the reason an early-stage company skips quality. No credit card. No hidden tiers. No catches. We're building this with you, not for you.
They generate documents. We generate clarity. When a founder walks into their first audit, the question isn't "did you fill out the FMEA?" It's "did you understand the risks you were taking and make deliberate decisions about them?" Document-first platforms miss this entirely.
Document first, understand never. Fill the form and hope an auditor doesn't ask why.
Understand first, document as you go. Every form is a learning opportunity, not a compliance burden.
FMEA table at the end of design — a retroactive exercise that rarely changes anything.
Risk management starts at concept stage. Risk tells you where to focus, not just what to file.
Change control means a DCO form, a committee meeting, and two weeks of delay.
Changes are captured in seconds — like a commit. AI assesses the impact; you confirm and move on.
Every module connects to every other. Your traceability matrix builds itself. Your DHF assembles automatically.
Three phases. One continuous loop. Quality becomes how you build — not something you do to your build.
Complete the foundational quality track for your role before touching a form. Understand why quality exists — not just what it requires. Every role gets a tailored path: founder, engineer, quality lead, consultant.
Document your design decisions as you make them, with AI guidance at every step. Capture user needs, link design inputs, assess risks in real time. Quality becomes a natural part of how your team works — not an after-the-fact task.
When your audit comes — FDA, ISO 13485, EU MDR — everything is already organized. Export a complete, auditor-formatted DHF in minutes. Not two weeks of scramble. Not a folder full of undated drafts.
Most eQMS tools are built by compliance consultants building compliance tools. Tangram eQMS is built by a founder and engineer who believes quality is a product design skill.
| Dimension | Traditional eQMS | Tangram eQMS |
|---|---|---|
| Device focus | Usually optimized for one device type. Hardware, SaMD, combination products, and IVDs are rarely all covered well. | Built for hardware, software, and combination devices. Full template library for design verification, manufacturing validation, and DHF. |
| Education | External courses sold separately. Fill the form and figure out the why on your own. | Embedded at every step. Every module includes the regulatory reasoning in plain language. |
| Risk management | FMEA table at end of design — a retroactive checkbox, rarely integrated with design decisions. | Living tool from concept stage. Risk drives design inputs, not just documents. |
| Design controls | Folder structure. Documents managed individually, no enforced traceability. | Enforced user need → design input → output → V&V traceability. Gaps highlighted automatically. |
| Change management | DCO forms, approval committees, days of delay for minor changes. | Log in seconds. AI assesses impact and assigns level. Proportional — not everything needs a meeting. |
| AI role | Fill in templates. Chatbot that knows your documents. | Proactive thinking partner. Flags gaps, suggests hazards, traces change impact before you ask. |
| Pricing | €499–$20,000+/month. Per-seat or document limits on free tiers that make them unusable. | Free during our founding period. No credit card. We grow when you grow. |
Cost should never be the reason a company skips quality. That's why we're free during our founding period — no credit card, no document limits, no gotchas.
Pricing announced at launch
Contact us to discuss
Join founders, engineers, and regulatory consultants who are building quality into their medical devices from day one — not bolting it on at the end.
Already have an account? Sign in →