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How we operate

Operational depth: quality, product development, configuration, and automation.

01 · Quality management

Universal QMS &
regulatory model.

One QMS. Five regulators. One strategic decision at TRL 5. Standing up a quality management system is the foundation that lets a medtech ship anywhere. The expensive mistake is building a regulator-specific QMS — locking yourself into one submission path before product-market fit is clear. We build a universal QMS infrastructure (ISO 13485, 14971, IEC 62304, 62366) and make the pathway decision at TRL 5. The QMS doesn't change. The submission package layered on top does.

sAibr inputs
Stakeholder insights
User needs
Risk definition
Claims boundaries
Clinical hypothesis
Regulatory positioning
Define scope
Universal QMS
Universal
QMSSystem infrastructure
ISO 13485
Medical device QMS
ISO 14971
Risk management
IEC 62304
Software lifecycle
IEC 62366
Usability engineering
Ready for
TRL 5 · Strategic decision
Which market first? Submission path locks in once product-market fit is clear.
Driven by product-market fit signal, payer landscape clarity, and clinical evidence position — typically late TRL 5 / early TRL 6.
Routes to
Regulatory pathways — 5 markets
Tap to expand FDA / EU / PMDA / TGA / NMPA
Regulatory pathways
FDA
510(k) / PMA
USA
Largest market. Pre-submission strategy critical for Class II / III.
+ 510(k) summary · PMA module
EU MDR
CE Mark
Europe
Required for any EU sale. Strict clinical evidence and post-market surveillance standards.
+ Technical file · CER
PMDA
Shonin / Ninsho
Japan
Fast-track tracks for innovative devices. English filings accepted in pre-consultation.
+ Shonin dossier · J-MDM
TGA
Class I – III
Australia
Regional reference market. EU MDR alignment streamlines parallel submissions.
+ ARTG application · conformity
NMPA
CFDA
China
Largest population market. In-country clinical data typically required.
+ NMPA dossier · in-country trial

Same QMS. Different submission package. Different timelines.

· Critical distinction

QMS is NOT the regulatory submission. QMS = system infrastructure. Device-specific regulations layer on top when you decide.

02 · Product development

8 stages, gate to gate,
TRL-aligned.

Eight gated stages from Proof of Principle through to In-Market. Three phases — Foundations, Validation, Production — each with a gate review at the boundary, so what ships into the next phase has already been signed off.

8 gated stages, three phases
FoundationsValidate the core
ValidationReal-world evidence
ProductionManufacturing readiness
1
PoP
2
PoC
3
Alpha
4
Beta
5
Pilot
6
Make
7
Market
8
PMS
01 · Foundations
PoP → PoC
Validate the core concept
  • Demonstrate it works
  • Refine problem-solution fit
  • Foundational design controls
02 · Validation
Alpha / Beta / Pilot
First functional builds
  • Real user feedback
  • Clinical / field evidence
  • Verification & validation
03 · Production
Make → Market
Manufacturing readiness
  • Supply chain & COGS finalised
  • Design transfer
  • Post-market surveillance live
Operating principles & gate philosophy
Tap to expand

Across all eight stages, four operating principles hold:

01
Regulator-first
Submission needs drive dev.
02
TRL honesty
No claiming TRL 7 on a TRL 5.
03
Design controls
DHF starts at concept.
04
Gate to gate
Quality at every step.

Plan it right, once.

03 · Configuration management

Integrated workflow
and records systems.

Two systems, one source of truth. One runs the workflow — tasks, dependencies, daily ops. The other holds the controlled records — versioned, audit-ready, regulator-grade. They sync live in both directions, so the work and the evidence stay aligned without anyone copying between systems.

Manages the work
Workflow system
Day-to-day operations
  • QMS task and workflow management
  • Project planning and collaboration
  • Linked workflows with live updates
Two-way sync
Live
Holds the records
Records system
Controlled doc storage and retrieval
  • QMS record repository with traceability
  • Single source of truth, version-controlled
  • Complete traceability — task to document
  • Audit-ready, not a scramble before the auditor
Operating principles
Tap to expand

The whole stack stands on four operating principles:

01
One source of truth
If it's in four places, it's in zero.
02
Risk-managed
Risk register lives in the workflow.
03
Audit-ready
Not a scramble before the auditor.
04
Cross-function
All disciplines, one Gantt.
04 · AI-powered business automation

Automation, agentic
workflows, live analytics.

Three escalating tiers of operational leverage. Tier 1 automates the mechanics; Tier 2 puts agents on multi-step research and drafting (humans still dispatch); Tier 3 wires live financial and project data straight into board reporting. Same toolset, different ambition.

Tier 1 · Automate
01 · Automate
Process improvement, AI-powered
  • Identify process bottlenecks
  • Develop workflows & automations
  • Deliver output smarter, faster, cheaper
Tier 2 · Agentic
02 · Agentic workflows
Agents propose, humans dispatch
  • Multi-step research and drafting agents
  • Draft reports in days not weeks
  • Source-linked outputs — every claim cited
Tier 3 · Live ops
03 · Reporting & analytics
Live, not lagging
  • Auto-compiled board, investor, partner reports
  • Financial snapshots from Xero
  • Project status from workflow system
Operating principles
Tap to expand

Across all three tiers, four operating principles hold:

01
Workflow first
Build the workflow; the model serves it.
02
Humans in the loop
Agents propose, humans dispatch.
03
Source-linked
Every summary cites its source.
04
Tool-integrated
Real endpoints, not toy demos.

Operational leverage for small MedTech teams — minutes, not days.

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