Why SaMD Companies Choose Akra.ai for Faster Time-to-Market

  


Executive Summary

Speed in Software as a Medical Device (SaMD) isn’t just about writing code faster. It’s about shipping the right, validated product—with traceability, clinical evidence, and regulatory documentation ready on day one. Akra.ai accelerates this journey by providing SaaS application infrastructure and built-in compliance automation that turn scattered activities—requirements, risk, verification, validation, clinical evaluation, cybersecurity, and post-market monitoring—into a single, auditable delivery pipeline. The result: shorter cycles, lower validation effort, and cleaner submissions—without compromising safety or quality.



SaMD Companies Choose Akra.ai for Faster Time-to-Market


The Problem SaMD Teams Face (and why time slips)

  • Fragmented toolchains: Jira + spreadsheets + shared drives = broken traceability and manual document assembly.

  • Late compliance: Teams “bolt on” ISO 14971, IEC 62304, and 21 CFR Part 11 after build—creating rework and delays.

  • Validation bottlenecks: Non-standard V&V, missing SAPs, unpowered studies, and undocumented environments.

  • Clinical & usability gaps: Designing claims, reader studies, and IEC 62366 usability too late in the cycle.

  • Adaptive AI challenges: No plan for model changes (PCCP), drift monitoring, or equity analyses.

  • Audit anxiety: Evidence exists, but not organized; submissions drag on due to inconsistent documentation.

Akra.ai: Built for Regulated Velocity

Akra’s platform brings product development + GxP-grade compliance together so teams can move quickly and stay audit-ready.

1) Compliance-First SaaS Infrastructure

  • Embedded standards mapping: Workflows aligned to IEC 62304 (software lifecycle), ISO 14971 (risk), IEC 62366 (usability), 21 CFR Part 11 (e-records/signatures), and IMDRF SaMD (intent & risk).

  • Out-of-the-box templates: Validation Plan (VMP), Statistical Analysis Plan (SAP), Dataset Cards, Model Cards, Predetermined Change Control Plan (PCCP), Post-Market Surveillance SOPs.

  • Automatic traceability: Requirements ⇄ risks ⇄ tests ⇄ defects ⇄ evidence, continuously maintained.

2) Validation Pipelines that “shift-left”

  • CI/CD + V&V: Unit/integration tests, simulated-use tests, and verification gates run on each build.

  • Environment pinning: Reproducible containers; versioned datasets/models; immutable artifacts for evidence.

  • Evidence assembly: Every run produces audit-ready packets (test reports, coverage, validation summaries).

3) Clinical & Usability Readiness

  • Claim-driven design: Tools to define intended use, performance targets, and clinically meaningful endpoints.

  • Study scaffolds: Reader study frameworks (MRMC), sample size calculators, SAP generators, and eCRFs.

  • IEC 62366 support: Formative/summative templates, task analyses, and residual-risk documentation.

4) AI/ML Lifecycle & PCCP Enablement

  • Model governance: Data lineage, labeling SOPs, inter-rater metrics, bias testing, calibration reporting.

  • PCCP blueprints: Scope of allowable changes, verification gates, rollback procedures, and monitoring triggers.

  • Real-world performance (RWP): Drift detection, subgroup surveillance, SPC charts, and CAPA hookups.

5) Security, Privacy, and Scale

  • Security by design: RBAC, audit trails, encryption in transit/at rest, SBOM generation, vulnerability scanning.

  • Privacy options: De-identification pipelines and region-aware data residency.

  • Cloud elasticity: Multi-tenant and single-tenant options with autoscaling for spikes in compute or traffic.

What “Faster Time-to-Market” Looks Like with Akra

Your mileage will vary by product class and claim. Teams typically report:

  • Weeks saved on assembling traceability and validation reports (automated evidence packaging).

  • Fewer resubmissions/queries because claims, endpoints, and risk controls are pre-aligned.

  • Shorter validation cycles thanks to standardized SAPs, powered studies, and repeatable test environments.

  • Smoother audits with live dashboards, versioned artifacts, and clean e-signatures.

End-to-End Workflow (How work flows through Akra)

  1. Define & Scope

    • Intended use, users, environment, risk category, preliminary claims

    • Auto-generated requirements set + risk register seeded from templates

  2. Design & Build

    • Architecture captured; 62304 class assignment; verification checklists attached

    • Secure repositories; pipelines scaffolded with test harnesses and evidence capture

  3. Validate

    • SAP locked; datasets versioned; reader/usability protocols created

    • Automated V&V + manual validation runs assemble structured outputs with CIs and calibration plots

  4. Document & Sign

    • 14971 risk files, test logs, deviations, DHF/tech file sections compiled

    • Part 11 e-signatures on reviews and approvals

  5. Submit & Monitor

    • Submission-ready bundles (claims mapping, validation results, transparency artifacts)

    • RWP dashboards track drift, equity, safety events; PCCP gates govern updates

Feature Highlights (Deeper Cut)

  • Traceability Matrix 2.0: Live, clickable links across requirements, hazards, mitigations, tests, and results.

  • Evidence Snapshots: Freeze a release and export the exact artifacts tied to it—rebuildable anytime.

  • Template Packs: VMP, SAP, HFE, cybersecurity checklist, labeling/transparency content, PCCP dossier.

  • Clinical Data Tooling: De-ID helpers, labeling QA, adjudication logs, and inter-rater reliability reports.

  • Equity & Bias Panels: Subgroup performance dashboards (site, scanner, sex, age, race/ethnicity, comorbidity).

  • Ops-Ready Monitoring: Real-time metrics, alert thresholds, on-call runbooks, and CAPA integration.

30 / 60 / 90-Day Acceleration Plan

Day 0–30: Foundation & Fit

  • Import/backfill existing requirements, risk items, and test plans

  • Stand up secure repos, CI/CD, and validation pipelines

  • Lock claims draft, intended use, and initial SAP outline

  • Quick wins: automated traceability and evidence export

Day 31–60: Validate & Harden

  • External/temporal validation cohorts curated; reader/usability protocols finalized

  • Robustness, calibration, and subgroup analyses automated in nightly runs

  • Risk file matured; usability summative planned; cybersecurity checks integrated

Day 61–90: Submission & Scale

  • Freeze candidate release; generate submission-ready validation package

  • PCCP drafted (if adaptive AI); post-market monitoring live

  • Run audit rehearsal; address gaps; finalize e-signatures

Compliance Mapping (Snapshot)

  • IEC 62304: Lifecycle classification, verification evidence, release records

  • ISO 14971: Hazard analysis, risk controls, residual risk rationale

  • IEC 62366: HFE plans, formative/summative results, IFU updates

  • 21 CFR Part 11: Electronic records/signatures, audit trails

  • IMDRF SaMD: Intended use, clinical evaluation depth tied to risk category

  • Adaptive AI: PCCP for pre-authorized changes; RWP & drift controls

(Akra aligns workflows to these frameworks; regulatory responsibility remains with the manufacturer.)

Example Outcomes (Anonymized Patterns)

  • Image-analysis SaMD (Class II): Cut validation packaging from ~6 weeks of manual collation to <1 week with automated evidence export; fewer regulator queries due to clear claims-to-evidence mapping.

  • Remote monitoring SaMD: Faster summative usability closeout via templated protocols; CAPA loop reduced cycle time with issue→risk→fix linkage built-in.

  • Adaptive ML SaMD: Smooth update cadence under a defined PCCP, with pre-set verification gates and drift triggers.

(Illustrative—not guarantees—actual results depend on scope, claims, and organizational processes.)

What Makes Akra Different

  • Compliance woven into delivery (not bolted on at the end).

  • Single source of truth for requirements, risks, tests, and artifacts.

  • Clinical-grade validation scaffolds (claims, SAPs, reader/usability) ready on day one.

  • AI-native governance (PCCP, drift, bias/equity) rather than generic MLOps.

  • Evidence on demand for auditors and regulators.

How to Get Started

  1. Discovery: Share intended use, target market, claims, and current artifacts.

  2. Blueprint: We map your lifecycle to Akra’s workflows and templates.

  3. Pilot: Stand up pipelines on a representative feature and produce a mini validation packet.

  4. Scale: Roll across modules; enable post-market monitoring and (if needed) PCCP.

FAQ (Short)

  • Will this replace our QMS?
    No—Akra integrates with your QMS and provides the operational rails and artifacts your QMS references.

  • Can we use our existing tools?
    Yes—Akra connects to repos, test frameworks, and data stores; it focuses on orchestration and evidence.

  • Do you support EU MDR/IVDR?
    We align to MDR/IVDR expectations through documentation packs (clinical evaluation, risk, usability) and can export region-specific bundles.


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