← Unovie.AI Agentic-Native SDLC · Regulated MedTech

ASMM-Med Assessment Scorecard#

A fillable, self-contained template for a quarterly maturity assessment. Select the satisfied level (0–5) for each of the eight dimensions and record the supporting evidence. Your governing level = min(D1, D4, D6) is computed live — capability can never outrun governance, evaluation, and security. Entries save to this browser; use Print to produce a PDF for the quality record. See the maturity model for full cell descriptors.

Governing level
Capability avg
D1Governance, Quality & Regulatorygoverning
QMS integration, IEC 62304 / ISO 13485 / QMSR alignment, CSA validation, traceability, change control
D2Model Infrastructure & MLOps
Self-hosted serving, fine-tuning pipeline, registry, reproducibility, multi-LoRA, GPU platform
D3Context & Knowledge Engineering
Specs, rule files, RAG over code/docs/regulatory corpus, memory, context hygiene
D4Evaluation, Validation & Assurancegoverning
Deterministic verifiers, eval suites, trajectory eval, the 99.9% gate, abstention
D5Agentic Orchestration & Tooling
Single → multi-agent, MCP/A2A, sandboxing, HITL design, workflow engine
D6Security & Zero-Trustgoverning
Identity, egress control, prompt-injection defense, supply chain, secrets, audit immutability
D7Observability & FinOps
Tracing, eval dashboards, token/GPU metering, routing economics, budget guardrails
D8People, Skills & Operating Model
Roles (conductor/orchestrator), review culture, training, approval-fatigue controls
Promotion rule. The overall operating level is the minimum across D1, D4, and D6. Advancing requires this scorecard plus documented evidence, signed by Engineering, Quality/Regulatory, and Security. Even at L4/L5, IEC 62304 Class C changes always require dual human control.

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