hey mela
Powered by Flowify AIPregnancy test evaluation via app — objective results, instant and private.
Key Results
- 4 months
- from kickoff to IVD-R certified
- 100+
- daily active users, growing
- Zero
- major findings in first audit
The Story
A woman buys a pregnancy test at the pharmacy. At home, she takes the test and waits. In the past, this moment meant squinting at a faint line under bathroom light, wondering if she's seeing what she hopes — or fears — she's seeing.
With hey mela, she opens the app. A built-in timer counts down the clinically validated reading window. When the timer ends, she holds her phone over the test strip. In under two seconds, the app delivers a clear, objective result — not a maybe, not a squint, but a clinically validated reading powered by on-device AI.
If the result is positive, the app tells her the estimated conception timeframe. No data leaves her phone. No images are stored. No cloud upload. The most private moment in healthcare stays exactly that — private.
The Partnership
Phaeosynt GmbH is a diagnostics company with deep expertise in lateral flow assays. They had developed a pregnancy test with strong analytical performance. What they wanted was something no one in the market offered: an app that evaluates the test objectively using AI — not as a wellness gadget, but as a fully certified IVD medical device under IVD-R.
They came to Liftric with the test strip, the clinical data, and the ambition. They did not have: a software development team, IEC 62304 experience, or a regulatory pathway for software as a medical device.
What Liftric contributed
- Regulatory strategy
- Classified the intended purpose, determined IVD-R requirements, designed the regulatory pathway from day one — not as a bolt-on after development.
- Architecture
- Designed a fully on-device processing architecture using the Flowify AI platform. No cloud dependency, no data transmission — critical for a product handling pregnancy data.
- Development
- Built the iOS and Android apps to IEC 62304 standards, with complete traceability from requirements through verification. Integrated the Flowify AI neural network for quantitative test strip evaluation.
- UX for a regulated product
- Created a consumer-grade interface that meets IVD-R requirements without exposing regulatory complexity to the user. Built-in timers ensure valid reading windows.
- Documentation & certification
- Produced the complete technical file. Supported TÜV Rheinland review. Zero significant findings in the first audit.
- Post-market
- Ongoing support for market surveillance and change management.
Liftric can take a diagnostics company from "we have a test strip and an idea" to "we have a certified, published, growing IVD app" — in four months, with zero audit findings. When Phaeosynt decided to include a software companion for their vegan, sustainable pregnancy test in the IVD submission, the clock was already ticking. We delivered in 4 months — from zero to fully certified IVD-R Home Use product, including both iOS and Android apps, complete IEC 62304 documentation, and successful approval under TÜV Rheinland. Today, over 100 people use the app daily to evaluate their pregnancy test results, and that number is growing.
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