marketing-medtech

**Country:** Spain (Madrid)
**Founder:** María González Manso — Co-founder & CEO (co-founder Marcos Rubio Rubio is CTO)
**Background:** tech | verified: True — Tech/engineering. María González Manso is a Biomedical Engineer — she earned a Bachelor's degree in Biomedical Engineering from Universidad Carlos III de Madrid (2013-2017), with study abroad in the same field at Universidade de São Paulo. She began her career as an Ultrasound Researcher at the University of São Paulo (2016), then worked in marketing/business innovation at medical-device company Medtronic (2017-2018), before becoming an Entrepreneur in Residence at Demium Startups (2018-2019) and co-founding Tucuvi (an AI voice-based virtual care/healthtech platform). She is consistently self-described and listed as a "biomedical engineer." Note: not a telecommunications engineer — the technical field is specifically biomedical engineering. The "tech" classification is accurate.
**Stage / fundraise:** Scale-up / Series A. Founded 2019 (~7 years old). Serves 60+ healthcare organizations, 50+ care pathways, claims up to 80% automation of nursing follow-up and >90% patient engagement. Has an in-house CTO and engineering team plus a dedicated QARA (Quality Assurance / Regulatory Affairs) function and is actively hiring more engineers. NOT an early-stage / no-CTO company. / $20M / ~EUR17M Series A closed Jan 2026 (Cathay Innovation + Kfund/Leadwind lead; Frontline, Seaya, Shilling participating)
**Regulatory trigger:** Strong but already largely handled in-house. Tucuvi is the first clinical Voice AI to obtain EU MDR Class IIb Software-as-a-Medical-Device certification for both its Voice AI agent and care-management platform, with CE marking and ISO 13485 certification already in place. Ongoing MDR/post-market obligations exist, but the company already runs its own QARA function and AI model validation process.
**Email:** maria@tucuvi.com (confidence low) — No published personal address found. A third-party aggregator (ContactOut) lists maria@tucuvi.com (first-name pattern) but this is unverified, hence low confidence. The only verified, company-published address is the general inbox info@tucuvi.com (from the official Tucuvi Series A blog post). Treat maria@tucuvi.com as a pattern-based guess only.
**LinkedIn:** https://www.linkedin.com/in/mariagonzalezmanso/ **Website:** https://www.tucuvi.com
**Score:** 5 -> Tier C
**Hook:** Weak hook for OmDev. Honest framing: Tucuvi already cleared MDR Class IIb + ISO 13485 and has its own CTO, engineering team and QARA function, so the core OmDev value props (dedicated CTO, outsourced tech team, compliance engine ~3x cheaper than in-house) do not match their situation. The only credible angle would be burst capacity for IEC 62304/MDR-traceable feature delivery during their EU+US scale-up, supplementing (not replacing) their team — but this is a long shot given a fresh $20M round funding in-house hiring. Recommend deprioritize.

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## Founder & background
María González Manso is Co-founder & CEO; Marcos Rubio Rubio is Co-founder & CTO. María is a Biomedical Engineer (Universidad Carlos III de Madrid) who worked in Marketing & Business Innovation at Medtronic and was an Entrepreneur-in-Residence at Demium before founding Tucuvi in 2019. Background is engineering/medtech, not finance/insurance. Both co-founders made Forbes 30 Under 30 Europe 2025 (Science & Healthcare). Sources: [Crunchbase](https://www.crunchbase.com/person/maria-gonzalez-manso), [Tucuvi/Forbes](https://www.tucuvi.com/blog/tucuvis-co-founders-featured-in-forbes-30-under-30-europe-2025).

## Funding & momentum
Closed a $20M / ~EUR17M Series A on 8 Jan 2026, led by Cathay Innovation and Kfund (Leadwind), with Frontline Ventures, Seaya Ventures and Shilling. Capital targets EU+US go-to-market, agentic/Voice AI development, and growing the engineering team. The company serves 60+ healthcare organizations across 50+ care pathways. Sources: [Tucuvi blog](https://www.tucuvi.com/blog/tucuvi-raises-20m-series-a-to-accelerate-adoption-of-its-ai-care-management-platform-across-healthcare-organizations), [EU-Startups](https://www.eu-startups.com/2026/01/spains-healthtech-startup-tucuvi-raises-e17-million-to-scale-lola-voice-ai-reporting-up-to-80-automation-in-nursing-follow-up/).

## Product & regulatory
LOLA is a clinical-grade Voice AI agent / AI care-management platform that runs autonomous patient phone conversations (post-discharge, chronic care, scheduling, medication) and escalates to clinicians. It is the first clinical Voice AI certified as EU MDR Class IIb SaMD, with CE marking and ISO 13485 already in place — and Tucuvi runs its own AI-model validation and QARA function. Sources: [MDR Class IIb](https://www.tucuvi.com/blog/tucuvi-class-iib-medical-device), [validation process](https://www.tucuvi.com/blog/how-tucuvi-validates-ai-models-to-meet-class-iib-medical-device-standards), [QARA hiring](https://tucuvipeople.factorialhr.com/job_posting/qara-specialist-289870).

## Pain & buying signals
This is a regulated SaMD scaling fast under MDR/IEC 62304 obligations — superficially OmDev's wheelhouse. But the ICP fit is poor: 7-year-old company, fresh $20M round, an in-house co-founder CTO, an established (and growing) engineering team, and a dedicated QARA function. They are deliberately hiring in-house, not outsourcing. The "non-technical founder / no CTO / thin team / needs a compliance engine" pains OmDev sells against simply do not apply. Sources: [backend engineer role](https://www.remoterocketship.com/company/tucuvi/jobs/backend-engineer-europe-remote), [Series A blog](https://www.tucuvi.com/blog/tucuvi-raises-20m-series-a-to-accelerate-adoption-of-its-ai-care-management-platform-across-healthcare-organizations).

**Why OmDev fits:** Honestly, it mostly doesn't. The only plausible angle is supplemental burst capacity for IEC 62304/MDR-traceable feature delivery during their dual EU+US scale-up — and even that is a long shot against a well-funded in-house hiring push backed by a CTO and an internal QARA team. Recommend Tier C / deprioritize and revisit only if hiring stalls. Verified company contact is info@tucuvi.com; maria@tucuvi.com is an unverified pattern guess.

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**Sources:** https://www.crunchbase.com/person/maria-gonzalez-manso · https://www.tucuvi.com/blog/tucuvi-raises-20m-series-a-to-accelerate-adoption-of-its-ai-care-management-platform-across-healthcare-organizations · https://www.eu-startups.com/2026/01/spains-healthtech-startup-tucuvi-raises-e17-million-to-scale-lola-voice-ai-reporting-up-to-80-automation-in-nursing-follow-up/ · https://www.tucuvi.com/blog/tucuvi-class-iib-medical-device · https://www.tucuvi.com/blog/how-tucuvi-validates-ai-models-to-meet-class-iib-medical-device-standards · https://www.tucuvi.com/blog/tucuvis-co-founders-featured-in-forbes-30-under-30-europe-2025 · https://tucuvipeople.factorialhr.com/job_posting/qara-specialist-289870 · https://www.remoterocketship.com/company/tucuvi/jobs/backend-engineer-europe-remote · https://www.linkedin.com/in/mariagonzalezmanso/ · https://contactout.com/Maria-Gonzalez-Manso-9613766