Join us in revolutionizing MedTech compliance
We're building the next-generation eQMS & ERP platform that unifies quality, compliance, and operations for regulated medical device companies. Backed by deep industry expertise and AI-powered innovation.
The Opportunity
MedTech companies are struggling with fragmented, outdated quality systems that slow innovation and increase compliance risk.
The Problem
- Fragmented systems create version chaos and siloed processes
- Manual compliance workflows slow time-to-market
- Legacy eQMS platforms are expensive and difficult to use
- Lack of integration between quality and operations
- Audit preparation is time-consuming and error-prone
Our Solution
- Unified eQMS & ERP platform with AI-powered workflows
- Real-time audit trails and automated compliance
- Built for engineers, trusted by auditors
- Native integrations for end-to-end traceability
- Designed to support FDA 21 CFR Part 11 and ISO 13485
Market Opportunity
Market Size
The global eQMS market is projected to reach $XX billion by 2028, driven by increasing regulatory requirements and digital transformation in MedTech.
- Growing MedTech sector with increasing compliance needs
- Shift from paper-based to digital quality systems
- Demand for AI-powered automation in regulated industries
- Expansion of digital health and SaMD markets
Competitive Advantage
We combine deep MedTech expertise with modern AI technology to deliver a platform that's both powerful and usable.
- Founders with 20+ years in regulated MedTech
- AI-powered workflows that reduce manual work
- Unified platform (eQMS + ERP) vs. fragmented solutions
- Modern, cloud-native architecture
- Focus on usability and developer experience
Traction & Roadmap
Our journey so far and what's next
Company Founded
Launched with founding team bringing decades of MedTech and software experience.
Platform Development
Built core eQMS platform with AI-powered workflows, document control, CAPA, and training modules.
Early Access Program
Launching pilot program with select MedTech companies to validate product-market fit.
Market Expansion
Scale customer base, expand ERP capabilities, and build partner ecosystem.
Experienced Leadership Team
20+ years of combined experience shipping regulated software and medical devices
Tim Xu, Ph.D., MBA
CEO
Visionary executive with 20+ years across medical devices and regulated software. Built and led teams delivering ISO 13485 and FDA 21 CFR Part 11 compliant products.
Rishabh Ostawal
CTO
Engineer across imaging, cloud, and AI systems with deep experience in MedTech. Leads platform architecture for auditability, performance, and developer experience.
Haidong Peng, Ph.D.
CDO & CFO
20+ years in product finance and QMS-driven operations with global leaders like GE Healthcare and Philips. Proven track record from prototype to commercialization.
Business Model
Revenue Streams
- SaaS subscriptions (per-user or per-module pricing)
- Implementation and onboarding services
- Training and certification programs
- Enterprise support and SLAs
Target Customers
- Early-stage MedTech startups (pre-market)
- Established medical device manufacturers
- Digital health and SaMD companies
- Life sciences companies requiring QMS
- CROs and contract manufacturers
Interested in Investing?
We're raising capital to accelerate product development, expand our team, and scale customer acquisition. Let's discuss how you can be part of transforming MedTech compliance.
Pitch Deck
Download our investor presentation
Our pitch deck includes detailed information about our market opportunity, product roadmap, business model, and financial projections.
Request Pitch DeckAvailable upon request after initial conversation