Sezata

We’re building Sezata · Launching Q1 2027

A better future for healthcare starts small.

The QMS that grows with you.

Start building your quality system from day one, even if you’re a team of one. Tell Sezata what you’re making and where you want to go. We’ll help turn the work you have into a foundation for what comes next.

Get on the waitlistSee how Sezata helps

Illustrative product concept

Our belief

Sustainable healthcare needs new ideas to become safe, useful products. The teams behind them deserve a clearer way forward.

Built for your starting point

Start where you are. Build toward where you want to go.

You bring the knowledge of your product. Sezata helps you put a quality system around it, at a pace that makes sense for the team you have today.

01

One founder. One idea.

Begin with a clear starting point for your QMS, without needing to be a QA expert first.

02

A team already building.

Bring your existing work together and turn scattered documents into a foundation you can grow.

03

A milestone in sight.

Choose the certification or market goal you’re working toward and focus on the QMS work that supports it.

AI that helps you do the work

You don’t have to build it alone.

Sezata helps you understand the requirements relevant to your company and device, then turns that understanding into practical work you can review and own.

A useful QMS begins with your real work, not a pile of generic templates.

Bring what you have

Use AI to help turn your existing documentation and product work into a QMS foundation.

Create what you need

Answer guided QA questions and turn your knowledge into reviewable drafts for the documentation you still need.

See what’s missing

Identify likely gaps against relevant requirements and see where to focus next.

Our approach to AI

Useful AI. Your data under your control.

Different tasks use specialized AI workflows for extraction, organization, gap review, guided interviews, and search. Sezata is being built to turn your existing work into a searchable, traceable quality system while your team stays in control of every decision.

How we intend to protect your data

EU-only processing

Our launch design keeps customer content and AI processing in the EU, using EU-based model providers.

No provider-side retention

We are selecting provider contracts and settings that prohibit storing your documents or prompts after processing, or using them to train models.

GDPR by design

Your files and approved records live in your Sezata workspace. We are building for data minimization, controlled access, processor agreements, and clear export or deletion paths.

What AI helps you do

  1. 01
    Bring your documents into focus

    Extract text from uploads, organize it into relevant records and templates, and keep it searchable, editable, and linked to its source.

  2. 02
    See gaps against your goals

    Compare the work you have with relevant requirements and your chosen milestones, then suggest missing evidence or next steps for your review.

  3. 03
    Build what is missing through a guided interview

    A guided AI interviewer asks the questions a QA professional would ask about your product and process. It flags missing decisions or evidence and turns your reviewed answers into traceable document drafts.

  4. 04
    Ask your own documents

    Find passages, earlier decisions, and open questions through plain-language search, with links back to the underlying records.

You make the final call

AI can ask, draft, extract, connect, and suggest. Your team reviews the answers and changes before they become approved QMS records. An AI suggestion is not a certification decision.

These are safeguards and capabilities we are building for launch. We will publish the provider list, processing locations, and retention details before Sezata becomes available.

Guidance in the flow of work

QA support before your first QA hire.

Understand requirements, improve documentation, and keep moving toward your goal with AI-powered guidance at your side. Spend less time untangling QMS busywork and more time building the product you set out to make.

Tell us what you’re building. Set your goal. Bring what you have. See what needs attention next.

Your path grows with your product.

Why we’re building Sezata

We started too late. You shouldn’t have to.

A founder climbing a path of scattered documents toward an organized destination

As founders, we waited too long to think about the quality system and certifications our product would need. Once we understood the requirements, we faced a steep climb: reconstructing decisions and documentation that should have been part of our work from day one.

Catching up can mean hiring experienced QA managers or consultants, with costs that can reach hundreds of thousands of euros. We’re building Sezata so a solo founder or small team can afford to start early, understand what applies, and build a QMS alongside the product—making the path toward certification more manageable.

Launching Q1 2027

Be there from the beginning.

We’re building Sezata for the founders and small teams bringing new medical devices into the world. Join the waitlist to hear about our launch and early access.

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