Changelog

Reguverse Assistant release history and update notes

v0.5.0 2026-04-27

Risk Management (RM) workflow -- Maintain structured hazard (HAZ) and control measure (RCM) data in the project; the system automatically applies the risk matrix and RPN/residual risk calculations, with AI-assisted analysis in the register. Generates formal outputs including the risk analysis sheet, Risk Management Plan (RMP), and Risk Management Report (RMR); export risk analysis to Excel, and RMP/RMR to Word.
Team plan -- The former Max premium tier is now oriented toward Team collaboration for enterprise teams: when eligible, the enterprise owner can create an organization; members share organization-level AI credits and organization-level translation credits, with invitations, a member/usage dashboard, and ownership transfer (eligibility and features are described in-product).

Plan and benefits copy -- Plan descriptions, entitlements, and in-app labels related to the Team plan are updated to avoid confusion with the legacy “Max individual premium” wording.

Regulatory Knowledge Base -- New "Regulations" tab with full-text browsing and search across EU MDR, FDA, and NMPA regulatory documents, with built-in reader.
Performance improvements -- Faster plugin loading and smoother interface responsiveness.

Action Required for Existing Users

If the "Regulations" tab does not appear after updating, please re-download and re-install:

Your account and data are not affected.

Clinical Evaluation workflow -- AI-assisted clinical evaluation covering literature search, screening, appraisal, and gap analysis.
Document generation -- CEP, CER, and DCR document generation with direct Word insertion.
User & subscription management -- Registration, subscription, and payment features.
AI Tools -- Built-in AI-powered tool suite.
Account security -- Two-factor authentication (TOTP) and identity verification (CN users).
Enterprise verification & contract signing -- Enterprise qualification verification and contract workflow.