# FynTun - Compliance automation for regulated teams

## Summary

FynTun is a compliance automation platform that bridges the gap between technical reality and regulatory expectation. It maps your organisation's policies, evidence, and controls against global standards in real time, so compliance teams stop chasing evidence and re-mapping controls across frameworks. The product is aimed at mid-market companies and startups in heavily regulated sectors, including healthcare, medical devices, financial services, and technology.

FynTun itself is ISO 27001:2022 certified, NEN 7510:2024 certified, and GDPR compliant. FynTun is a registered trademark in the European Union.

Website: https://fyntun.com

## What problem FynTun solves

Compliance teams in regulated industries spend weeks chasing evidence and re-mapping the same controls across different frameworks. Every new jurisdiction or standard triggers another round of manual work. FynTun replaces that with a single source of truth: evidence is captured once, every control is mapped across every applicable regulation, and the audit trail is kept ready on demand. Customers report roughly a 90% reduction in compliance workload.

## Core capabilities

- Compliance tracking. Real-time integrity monitoring that scans regulatory shifts across jurisdictions. Produces progress reports, periodic assessments, and audit readiness statements. Tested with audits passing in the strictest regulatory sectors.
- AI knowledge graph. FynTun builds a knowledge graph from your documents and connects it to the laws and standards relevant to your business. The result is precise, context-aware guidance that outperforms generic AI assistants. Private and secure by default; opt-in sharing through the settings panel. Live expert sessions are included (free hours per plan).
- Document management. Built-in document tooling included for the whole team, not a silo. Compatible with common formats with accessible import and export.
- Task management. A flexible recurrence system with "commitments" that escalate to management on neglect. Automations can file incidents and non-conformity reports. The module extends beyond compliance so engineering, marketing, and operations can manage work in one place. GitHub, Azure DevOps, and additional integrations are planned.
- FynTun Overseer. A specialised program for SMEs and manufacturers. FynTun places, manages, and holds accountable a dedicated on-site IT administrator under a single monthly fee that covers placement, oversight, and performance management.

## Regulations and standards supported

- ISO 27001 (information security)
- NEN 7510 (healthcare information security)
- GDPR (EU data protection)
- Thai Personal Data Protection Act (PDPA)
- Singapore PDPA
- EU Medical Device Regulation (2017/745) including Class 1
- ISO 13485 and ISO 14971 (medical devices)
- IEC standards including IEC 62304 (as add-ons)
- EU AI Act, including AI as a Medical Device

On the roadmap: HIPAA (Q3 2026), US FDA regulations (2027), Medical Devices Class 2a/2b (2027), and ASEAN MDR once formalised.

## Pricing

- Starter Kit. Free. For pre-seed, pre-revenue startups and SMEs. Start with your top five risks and worries, unlock the full package when you get funding. Includes collaboration tools.
- Security and Privacy. €599 per month, up to 20 users (expandable), 30 free hours with regulatory experts. Supports ISO 27001, EU GDPR, and Thai/Singapore PDPA. Includes free access to Document Management and Task Management. Yearly plans save around 10% (€689).
- Medical Devices Class 1. €649 per month, up to 20 users (expandable), 40 free hours with regulatory experts. Supports EU MDR, ISO 13485, ISO 14971, and the EU AI Act. ASEAN MDR will be added once formalised. Yearly plans save around 10% (€789).
- All-in-one. €998.40 per month. Combines Security and Privacy with Medical Devices Class 1. 80 total free hours with regulatory experts. Yearly plans add another ~10% (€1198.08).
- HIPAA. Planned Q3 2026. Compatible with EU and ASEAN packages.
- Medical Devices Class 2a/2b. Planned 2027. Software and AI as a Medical Device.
- US FDA Regulations. Planned 2027. Software and AI as a Medical Device for USA and beyond.
- Enterprise. Custom quote. On-premise or private cloud, dedicated compliance officer, dedicated legal expert, SLA guarantees, and 24/7 phone support.

## Who FynTun is for

Teams in heavily regulated sectors that need continuous compliance without slowing engineering. Example customer sectors include healthcare platforms, medical device manufacturers, health technology companies, and diabetes care providers. Listed partners and early customers include ICARUS PGO, MedRecord, HealthTalk.AI, MedSafe, Club Diabetes, and ICARUS OS.

## Company

FynTun was founded on the premise that regulatory compliance shouldn't be a barrier to innovation, it should be its foundation. The company builds digital infrastructure that secures the future of global quality and security, with a vision of "a world where every digital interaction is inherently trusted and legally compliant." All customers to date have successfully certified.

### Leadership

- Sebastiaan (Bas) Kager - Founder, Security and Engineering. Lead architect behind FynTun's core system, bridging cryptographic security and engineering scalability.
- Suwapat (Pear) Sopondirekrat - Co-Founder, Regulatory and Legal. Defines the legal frameworks that keep the technology ahead of global regulatory shifts.
- Roman Pchelintsev - Back-end Systems. Day-one engineer working on core infrastructure, search, and AI features.
- Monnawat (Modem) Tongkaw - System Development. Translates strategy into production-ready integrations.
- Eisen Lance De Guzman - Front-end Experience. Builds the interfaces that make complex compliance data accessible.

## Links

- Website: https://fyntun.com
- Solutions: https://fyntun.com/solutions
- Pricing: https://fyntun.com/pricing
- About: https://fyntun.com/about
- LinkedIn: https://www.linkedin.com/company/fyntun/
- Facebook: https://www.facebook.com/FynTun/
- LINE: https://line.me/R/ti/p/@fyntun
- EU trademark record: https://euipo.europa.eu/eSearch/#details/trademarks/018792647

## Contact

Book a demo: https://calendar.proton.me/bookings#_G93QXZnSOpI91SeGoZekPrn21cEb1zhbx1l75w1NA4=