Medical Software That Complies

We combine advanced medical software development with comprehensive regulatory consulting. From concept to market approval - streamlined, compliant, and efficient.

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TGA Compliant
FDA Ready
EU MDR

Our Integrated Approach

We don't just build software and hope it passes regulatory review. We design compliance into every line of code from day one.

Development Excellence

Software as Medical Device (SaMD)
Clinical Decision Support Systems
Mobile Health Applications
AI/ML Healthcare Solutions

Regulatory Mastery

TGA, FDA, EU MDR Expertise
Clinical Evidence Strategy
Quality Management Systems
Risk Management & Documentation

The Result? Revolutionary Speed

3X
Faster Time to Market
∞
Time and Cost Savings
100%
Regulatory Confidence

Bridging the Gap Innovation & Compliance

Traditional medical device development separates software engineering from regulatory compliance, creating expensive blind spots and delays.

We've reimagined this process. By weaving regulatory expertise into every sprint, every code review, every design decision, we build compliance into your software's DNA.

Traditional

Build first
Hope it complies
Expensive rework

Our Way

Design for compliance
Built-in validation
First-time approval

"VCs are more likely to invest in medtech start-ups with a clear regulatory pathway and solid clinical evidence."

— Deloitte Healthcare Investment Report

Meet the Vitastical Team

The perfect fusion of clinical mastery and engineering excellence. Two industry veterans who've revolutionised how medical software gets built.

Dr. Jason Jin - Clinical Research Scientist & Medical Doctor at Vitastical

Dr. Jason Jin

Clinical Research Scientist & Medical Doctor

The clinical genius behind our regulatory mastery. 20+ years turning complex medical research into breakthrough solutions that save lives and satisfy regulators.

Clinical Research Biostatistics Regulatory Strategy
20+
Years Experience
50+
Projects Led
20+
Clinical Trials
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Fred Wu - Software Consultant & CTO at Vitastical

Fred Wu

Software Consultant & CTO

The engineering virtuoso who transforms complex requirements into elegant, secure and scalable solutions. 20+ years building systems that millions depend on.

Full-Stack Engineering AI/ML Cyber Security
20+
Years Experience
100+
Open Source Projects
20+
Startups
Connect on LinkedIn

The Perfect Partnership

When clinical expertise meets engineering excellence, magic happens. Jason understands what regulators need. Fred builds what users love. Together, we create software that not only works, but transforms healthcare.

The Trusted Network

We've built a network of trusted partners who share our passion for innovation and excellence in the regulatory and compliance space. These are industry leaders and veterans who have been in the trenches and understand the challenges of navigating the regulatory landscape.

Our Story: Where Innovation Meets Purpose

In the bustling corridors of one of Australia's leading healthcare companies, two paths converged in the most unexpected way. Dr. Jason Jin, a clinical research scientist meticulously reviewing regulatory submissions, crossed paths with Fred Wu, the CTO brought in to modernise the company's digital infrastructure.

What started as a brief hallway conversation about a challenging clinical trial turned into a multi-hour whiteboard session. Jason explained the regulatory nightmares that kept him awake at night. Fred sketched elegant technical solutions that could prevent them. By the end of that impromptu meeting, they both knew they'd found something special – a shared vision for what healthcare technology could be.

Over countless coffee meetings and late-night discussions, they discovered their complementary skills created something neither could achieve alone. Jason's deep understanding of clinical needs and regulatory requirements perfectly balanced Fred's ability to build robust, scalable systems. More importantly, they shared a fundamental belief: that great medical software shouldn't have to choose between innovation and compliance.

The Serendipitous Meeting

Two experts from different worlds discover a shared passion for transforming healthcare technology.

The Lightbulb Moment

Realising that integrating development with compliance from day one could revolutionise medical software delivery.

Building Vitastical

Combining decades of expertise to create a new paradigm for medical software development.

"When clinical insight meets engineering excellence, we don't just build software – we transform how healthcare innovation comes to life."

- Jason & Fred

Regulatory Excellence Built In

We navigate the complex regulatory landscape so you can focus on innovation. Our deep expertise in international medical device standards ensures your software meets global compliance requirements from day one.

TGA

TGA Essential Principles

Australia's cornerstone regulatory framework ensuring medical device safety and performance throughout the product lifecycle.

  • Mandatory for Australian market access
  • Harmonised with international standards
  • Risk-based classification system
IEC

IEC 62304

The gold standard for medical device software lifecycle processes, ensuring systematic development from concept to retirement.

  • Safety-based software classification
  • Agile-compatible framework
  • FDA recognised consensus standard
ISO

ISO 13485

The internationally recognised quality management system standard specifically designed for medical device organisations.

  • Global regulatory acceptance
  • Risk-based approach to QMS
  • Harmonised with EU MDR/IVDR
ISO

ISO 14971

Comprehensive risk management framework for medical devices, ensuring systematic identification and control of potential hazards.

  • Benefit-risk analysis framework
  • Lifecycle risk management
  • Mandatory for major markets
IEC

IEC 62366

Human factors and usability engineering standard ensuring medical devices are safe, effective, and intuitive for users.

  • User-centred design approach
  • Use error risk mitigation
  • FDA recognised standard
+

Beyond the Basics

We stay current with evolving regulations and emerging standards to future-proof your medical software.

  • FDA Software Precertification
  • EU MDR/IVDR compliance
  • Cybersecurity frameworks

Compliance Confidence from Day One

Our regulatory-first approach means your medical software is designed with compliance built into every line of code, not bolted on as an afterthought.

100%
Regulatory Success Rate
3x
Faster Market Entry

Global Market Access

Navigate TGA, FDA, CE marking, and other international requirements with confidence.

Risk-Based Development

Integrate risk management throughout the development lifecycle, not just at the end.

Audit-Ready Documentation

Maintain comprehensive technical files that satisfy the most stringent regulatory reviews.

Ready to Transform Your Medical Software Vision?

Don't let regulatory uncertainty delay your innovation. Let's build compliant, market-ready medical software together.

Get in Touch Schedule a Free Consultation

Free initial consultation • No obligation • Fast response within 24 hours