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SaMD platform
LaunchPad

Venture-ready SaMD platform. Built for regulated medical software.

Ready for global approval, secure by design. LaunchPad lets MedTech ventures onboard new device programs faster — on a platform that evolves from PoC through to commercial deployment, with regulatory and security baked in from day one.

01 · Three pillars

Compliance baked in.
Security in, not on.
Configurable, not bespoke.

Three things every venture-grade SaMD platform needs.

01 · Regulatory core
Compliance baked in
Submission-ready, day one.
  • IEC 62304, ISO 13485, 14971, IEC 62366
  • FDA, PMDA, TGA, EU MDR pathways
  • Risk, usability, lifecycle integrated
  • Design controls and DHF templates included
02 · Security & data
Enterprise-grade, day one
Encryption ships day one.
  • AES-256 at rest, TLS 1.3 in transit
  • RBAC, MFA, full audit logging
  • GDPR, HIPAA, AU Privacy aligned
  • Tenant isolation by default
03 · Extensible
API-first, AI-ready
Re-use across programs, not bespoke.
  • Modular, multi-tenant + white-label
  • Multiple concurrent device programs
  • AI-ready (ISO/IEC 42001 alignment)
  • Partner-delivered with platform integrators

"Built for regulated medical software — ready for global approval, secure by design."

Onboard new device programs faster — on one evolving platform.

02 · Platform evolution

PoC to commercial
deployment.

Four staged platforms, building toward multi-site clinical and commercial scale.

1
Proof
Integrated PoC
Stage 1
  • Wearable device
  • Mobile app
  • Basic cloud pipeline
2
Structure
Pre-Clinical
Stage 2
  • Structured data & analytics
  • Annotation & AI integration
  • Secure data storage
3
Validate
Clinical Trial
Stage 3
  • Secure data management
  • Trial workflow support
  • Cloud infrastructure
4
Scale
Commercial
Stage 4
  • Multi-site scalability
  • Analytics dashboards
  • Fleet management

From PoC to commercial deployment on one evolving platform.

03 · Standards & specs

Built to the standards
regulators read.

Every layer — software, data, security — aligned to the standards your submission will reference.

Software lifecycle
IEC 62304
Medical device software — software lifecycle processes, integrated end-to-end.
Quality management
ISO 13485
Medical device QMS aligned, ready to extend to specific submissions.
Risk management
ISO 14971
Risk management process integrated across the platform.
Usability engineering
IEC 62366
Usability engineering for medical devices — built into the design controls.
AI management system
ISO/IEC 42001
AI management system alignment — for AI-ready medical software.
Regulatory pathways
FDA · PMDA · TGA · EU MDR
Submission scaffolds for the four major medtech regulators.
04 · Operating principles

How LaunchPad behaves
across programs.

01
Configurable
Re-use across programs, not bespoke.
02
Regulatory default
Compliance isn't a feature.
03
Security in, not on
Encryption ships day one.
04
Partner-delivered
White-label model with platform partners.
Get in touch

Have a SaMD program
worth launching?

We're happy to walk through how LaunchPad fits your program — 30 minutes, founders only, no deck. Bring the regulatory pathway you're targeting and we'll show you what shipping on LaunchPad looks like.

Email
hello@solentropy.com.au
Office
Melbourne Connect, Swanston Street, Carlton VIC
Sister platform
sAibr™ — research intelligence layer →