ins2outs pricing
Built to grow with you. Priced the same way.
The platform covers your full management system across Quality, Security, Privacy, and AI. Know-How Sets are purchased separately for each standard you need. You build and pay only for the scope that matches your product, markets and maturity.
Platform pricing
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.
Plug-in expert knowledge pricing
Each Know-How Set is a complete content library for a specific standard: policies, processes, procedures, document templates, normative sources, and role assignments, all pre-structured and ready to load into ins2outs.
ISO 13485 / 21 CFR 820
€6,500 / set
For medical device manufacturers entering the EU, US, or global markets.
Gets you a pre-built QMS content library mapped to ISO 13485, MDR/IVDR, FDA, and TGA requirements, ready for your first audit.
IEC 62304
€8,000 / set
For software teams building medical devices or SaMD.
Gets you a structured software development lifecycle without rebuilding your engineering process from the ground up.
ISO 42001
€6,500 / set
For teams building, deploying, or using AI products.
Gets you 94+ document templates, processes, and controls mapped to ISO 42001 — the foundation for AI governance certification.
EU AI Act
€6,500 / set
For teams developing or deploying AI systems in the EU.
Gets you a governance framework aligned to the Act’s risk classification tiers, ready to demonstrate to notified bodies and enterprise customers.
EU Cyber Resilience Act (CRA)
€6,500 / set
For teams shipping connected hardware or software products into the EU.
Gets you the documentation and evidence structure to meet CRA obligations before the enforcement deadlines land.
ISO 27001
€6,500 / set
For teams establishing or formalising security management.
Gets you the policies, processes, and controls needed to certify to ISO 27001 and pass an external audit.
GDPR
€2,500 / set
For teams that need data privacy accountability.
Gets you the policies, templates, and controls needed to demonstrate GDPR compliance to customers, regulators, and data subjects.
Expert support, when the platform alone isn't enough
ins2outs is built by Star, a global regulatory consultancy with years of experience working across medical devices, AI products, and regulated software. For teams that need hands-on support alongside the platform, Star’s consulting services are available at every stage. Pricing is scoped to each engagement. Talk to the team to discuss your situation.
Regulatory strategy
For teams that need clarity before they build. Defines your regulatory pathway, classifies your product, identifies applicable standards, and closes the gaps before they become blockers.
Platform implementation
For teams standing up a management system for the first time. Sets up your QMS, ISMS, AIMS, or PIMS end to end — scoped to your organisation, mapped to your products, and ready to certify.
Gap assessments
For teams preparing for an external audit or reviewing an existing system. Identifies what’s missing, what’s misaligned, and what needs to be resolved.
Market placement
For teams bringing a regulated product to a new jurisdiction. Covers conformity assessment support, notified body interactions, in-country representation, and PRRC enablement.
Post-market support
For teams with certified products that need to stay compliant. Keeps your management system operational across regulatory updates, new product lines, and market expansion.
Training and upskilling
For teams managing compliance without a dedicated specialist. Builds the internal capability to own and operate your management system without depending on external support.
Start with a conversation
Licences, Know-How Sets, and consulting can be combined in different ways depending on where you are. We’ll help you work out what makes sense.