Changelog

What we have shipped

A running record of what has changed and when.

v0.19 14 July 2026

Evidence coverage, onboarding flow, and release confidence

  • - Expanded browser coverage across document approval, training assignment, member training completion, management reviews, reminders, release evidence links, and product onboarding paths
  • - Getting-started checklist refined so approving the first controlled document completes the first approval milestone while broader SOP follow-up remains visible in recommended actions
  • - Release evidence linking strengthened with coverage for requirements and CAPAs, including add, remove, persistence, and product-scope protections
  • - Deployment confidence improved with read-only health and public-page smoke checks that confirm application availability without touching customer records
v0.18 8 July 2026

Validation pack, standards support, and security controls

  • - QMS software validation pack introduced with versioned source, private printable export, seeded validation records, and CI coverage for validated workflows
  • - Standards and guidance content expanded with structured crosswalks, course material, and an evidence spine for SaMD teams working through ISO 13485, IEC 62304, ISO 14971, and related expectations
  • - Security posture strengthened with MFA support, tighter content security policy handling, structured security events, dependency monitoring, and production configuration checks
  • - Backup, deployment, and data-store guardrails improved for operational reliability across production environments
  • - Privacy and consent controls updated with GDPR cookie handling, legal page coverage, and customer-facing website refinements
v0.17 21 June 2026

Classification guidance and public resource improvements

  • - SaMD classification guidance expanded with rule-based decision support, clearer references, and stronger handling of diagnostic, monitoring, closed-loop, and device-driving software scenarios
  • - Public education resources improved with release planning content, classification resources, and clearer paths for founders comparing QMS options
  • - Customer-facing copy refined around pricing, demos, and course access so the website better reflects how teams engage with QualiHQ
  • - Production queue and deployment handling refined to support more predictable runtime operation
v0.16 10 June 2026

Supplier register, management review, and release validation

  • - Supplier register expanded with risk levels, approval dates, automatic review intervals, overdue review indicators, and health-check visibility
  • - Management review records added to the Audit area with documented inputs, decisions, actions, and password-authenticated approval
  • - Release records expanded with validation detail for method, participants, scenarios, outcomes, and issues found
  • - Controlled document boilerplate broadened for ISO 13485-aligned operations, including vigilance, supplier management, design and development, quality policy, roles, and issue management content
  • - Health checks expanded for validation records, supplier review status, management review cadence, and required operating records
v0.15 3 June 2026

Pricing clarity and capability packaging

  • - Pricing and capability pages refreshed to make plan differences easier to compare
  • - Plan packaging clarified around core QMS records, health-check support, management review workflows, and AI-assisted generation
  • - Paid plans simplified around flat-rate access with unlimited seats and products
  • - Onboarding and application bootstrap paths refined for a smoother first session
  • - Customer-facing copy tightened so product capabilities are presented clearly without overloading early evaluation
v0.14 27 May 2026

Compliance health check and team invitations

  • - Compliance health check — an automated scan of your QMS that checks whether required records exist and are in the right state. Covers requirements with no verification, stale test evidence, unapproved SOPs, open complaints past their deadline, incomplete training, missing risk review, and more. Each finding links directly to where the gap needs to be closed. Results are scored and stored as an auditable record
  • - Team invitations now delivered by email. Members receive a direct link to accept their invite and set up access — no copy-paste required
  • - Issues renamed from Bugs throughout the app — the correct term under ISO 13485 §8.3 and IEC 62304 §9. Existing records are unchanged
  • - Release approval now blocked if any linked requirements are still in draft — unapproved requirements cannot be included in an approved release
v0.13 20 May 2026

Design History File viewer

  • - Every release now has a Design History File view — a structured, auditor-ready document covering the complete design control record for that version: requirements, verification evidence, risk sign-off, dependency snapshot, open issues, CAPAs, document register, and completeness declaration
  • - A 7-point completeness score grades the DHF green, amber, or red. Each failing check includes specific guidance on exactly what to resolve and where
  • - The DHF is available at any stage — draft releases show a live preview so gaps can be identified and closed before approval
v0.12 13 May 2026

Risk management and post-market surveillance

  • - Per-release risk review: each release now includes a risk tab showing new and changed risk items since the previous version. Reviewers approve items individually and complete the review with an electronic signature
  • - AI-generated risk analysis: provide your product description and existing requirements and QualiHQ will produce a structured starter risk register covering hazards, probabilities, severities, and mitigations
  • - Post-market surveillance procedure generated automatically on account creation, covering monitoring tool placeholders, review cadence, alert thresholds, and assigned roles — ready to review and approve
v0.11 6 May 2026

Training records, dependency management, and safety classification

  • - Training records now tracked per document per team member. Training is assigned automatically when a document is approved, and the Team page shows completion status across the full team at a glance
  • - Dependency file import: upload a package.json, requirements.txt, go.mod, Gemfile.lock, or composer.json to populate your SOUP inventory in one step. Duplicates are updated automatically with a change count returned
  • - IEC 62304 software safety classification added to product settings. The selected class surfaces in release records and the Design History File
v0.10 5 May 2026

Approval security, traceability refinements, and compliance chain

  • - Strengthened electronic signature security across all approval actions, providing a stronger audit trail for regulatory submissions
  • - Traceability view refined for larger requirement sets
  • - Traceability matrix now shows the first release a requirement appeared in and the release in which it was last active, giving a clearer view of requirement history across versions
v0.9 29 April 2026

Design history traceability and dashboard overhaul

  • - New traceability matrix view showing the complete design control chain from approved requirements through verification methods to test evidence -- making full traceability easy to maintain and straightforward to demonstrate
  • - Compliance coverage chain added to the dashboard: five-stage visual showing how many requirements have been approved, verified, tested, and passed -- with drop-off counts at each stage
  • - Dashboard recommended actions reorganised into labelled groups by area -- requirements, documentation, issues, and releases -- each with a health indicator so the most urgent area is immediately visible
v0.8 22 April 2026

Regulation guides, onboarding refinements, and test infrastructure

  • - Added a free guides section covering medical device regulation for software teams. Plain-English explanations of EU MDR, SaMD classification, and when your app needs a QMS
  • - Streamlined the new account setup flow. The DPA step is now added to settings and setup now completes faster with fewer decisions upfront
  • - Expanded automated end-to-end test coverage across core workflows including sign-in, onboarding, and document approvals
v0.7 15 April 2026

Onboarding, in-app guidance, and security hardening

  • - Added a getting started checklist that persists across every page, tracking setup progress from first bootstrap through to first release and team invite
  • - Added a three-step QMS explainer on first login covering how requirements, verifications, test runs, SOPs, releases, and audits work in plain language
  • - Required SOP templates now ship with every new account and are flagged in the documents table until approved
  • - Security: XML upload hardened against external entity injection, rate limiting added to all AI endpoints, login brute force protection tightened, API tokens now expire after 30 days, password complexity enforced on registration
v0.6 8 April 2026

Release UI overhaul, security hardening, and public changelog

  • - Rebuilt the release approval UI with a cleaner step-by-step flow and inline warnings for missing verifications or unreviewed risk items
  • - Security hardening: Content Security Policy headers tightened, security.txt published, GDPR sub-processor records updated
  • - Added this changelog
v0.5 2 April 2026

Smarter AI linking and traceability improvements

  • -- Significantly improved how the AI links requirements to verifications -- higher accuracy on ambiguous or overlapping requirements
  • -- Traceability matrix now shows link confidence and flags any requirements with no verification coverage before you proceed to release
  • -- Priority system added to requirements: each item now carries a risk-weighted priority score to help teams focus review effort
v0.4 26 March 2026

Onboarding overhaul and bootstrap improvements

  • -- Simplified the bootstrap wizard from five steps to three -- describe your product, add test results, review and apply
  • -- New users can go from signup to a populated QMS in under two minutes
  • -- Context input imporvements for onboarding including a full detailed design doc or README
v0.3 19 March 2026

Release workflow and audit trail

  • -- Release approval workflow shipped: releases are now blocked until all verifications are linked and the risk assessment has been reviewed
  • -- Full audit trail: every action logged with timestamp, user, and context
v0.2 14 March 2026

AI bootstrap shipped

  • -- AI bootstrap: describe your product and get a complete QMS structure generated in seconds -- requirements, verifications, risk analysis, and traceability matrix
  • -- Requirements include references to the relevant parts of your codebase, derived from the context you provide
  • -- Issue tracking and CAPA management
  • -- Team invites and role-based access
v0.1 10 March 2026

First release

  • -- QualiHQ is live
  • -- Requirements management, verifications, and test case tracking
  • -- Risk analysis with hazard identification and mitigations
  • -- Release management, issue tracking, and CAPA workflow
  • -- Traceability matrix linking requirements, verifications, and test evidence
  • -- HTTPS enforced, rate limiting in place, security headers configured

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