AI Module · Complaint Management
AI-assisted feedback and complaint management
- ✓ AI summary and IMDRF classification
- ✓ Reportability assessed with reasoning
- ✓ Human review before every closure
The challenge
For medical device manufacturers, every product complaint starts with manual work
All of that happens before anyone starts investigating. It is slow and repetitive, it varies from person to person, and it is exactly where reporting deadlines are put at risk.
The solution
ins2outs turns incoming complaint emails into structured, pre-classified complaint records automatically
How it works
Your quality team starts with a complaint that is ready to review
Connect a mailbox to each product
Choose where complaints are filed, which template they use, and who owns them. You decide which fields the AI fills and which your team completes.
AI reads every complaint
It analyses the email together with any PDF attachments, in the context of the product and how it is meant to be used.
A structured record is created
Each new complaint arrives with:
- a clear summary of the issue
- IMDRF and other categories
- an assessment of whether it must be reported to a regulator, with the reasoning and a confidence level
- a cybersecurity relevance flag
- links to similar past complaints for that product
Handling starts right away
The owner is assigned and an investigation starts. The original email and attachments are kept on the record.
Your team stays in control
Complaints move through a dedicated workflow (New, Under Investigation, Closed or Rejected) and always need a human review before they are closed or rejected.
Every AI-filled field is tracked
ins2outs shows you how often the AI’s classification was accepted without changes. That gives you hard evidence of its accuracy over time, so you can expand its role as you come to trust it.
Why it matters
Spend expert time on investigation and judgement
Less manual triage
The AI does the first pass, and your experts focus on investigation and judgement.
Consistent classification
The same categorisation logic is applied to every complaint, every time.
Clearer reporting decisions
Every reportability assessment comes with its reasoning, so reviewers can confirm or correct it quickly.
Built for audits
The original email, attachments, AI analysis and review history are all kept with the complaint.
See patterns sooner
Automatic links to similar past complaints help you find recurring issues faster.
Live dashboards
Complaint volume by category, the number of complaints resolved within SLA, and how often the AI’s first pass needed no correction.
All your complaints. One platform. One source of truth.
Complaints management is one module inside ins2outs, a compliance platform that covers quality, information security, AI management, and data privacy in a single connected environment.
Standard
Light-weight for a smooth start- One organization
- Public cloud configuration
- Customizable workflows
- User Access and Management
- Import and Export
- KPIs, Report and Stats
- Mapping to Standards and Regulations
- User Compliance tracking
- 5h of onboarding support
Premium
Perfect for growing organization- Everything in Standard +
- Slack support channel
- Multi-Factor Authentication
- SSO over SAML2
- CFR part 11 compliance
- Integrations (Slack, Teams, GitLab, OpenAI etc.)
- Risk management, requirements, traceability
Enterprise
Custom needs - custom offering- Everything from Premium +
- Unlimited storage
- Private cloud deployment is possible
- Dedicated service delivery team
- Enterprise support
- Client customizable WAF
- Features development on demand**
AI Modules
Delegate effort-heavy tasks- Standard or Premium Plan is required for AI Modules
- AI-Driven Literature Review
- Risk FIle Generation
- Regulatory Intelligence
- Complaints handling
*Minimum 5 users to start for any subscription plan. Volume discounts apply for organizations from 100 users.
** Scope and timeline are defined within the contract.
All prices are net prices.
Ready to automate complaint management?
Let AI do the first pass on every complaint so your experts spend their time on investigation. Book a 30-minute demo and we’ll walk you through complaint intake, AI classification, and the review workflow.