Built for teams that innovate in regulated environments
Integrated management system for Quality, Security, Privacy, and AI compliance with pre-built know-how sets for every major standard. Ready to use in hours
%
faster implementation
%
audit pass rate
%
customers never leave
TRUSTED BY
Compliance solutions for every stage
How you handle compliance determines how fast you grow
Every regulated product hits the same structural moments — first certification, new market, new standard, growing team. Start late, and you redesign. Scale on the wrong foundation, and you rebuild. Patch tools together, and you slow down. The architecture matters at every stage.
Here’s how ins2outs helps.
Build foundation
How can teams build a strong compliance foundation?
Certification influences product decisions, enterprise deals, and market access. Starting late often means redesign, rework, or delayed revenue. And a quality gap can mean direct liability, fines, or losing market access.
How ins2outs helps
~2 hours
to the operational workspace
- Product compliance roadmap, path to market, and eQMS
- Ready-to-use SOPs and templates for multiple markets and technologies
- Simplified compliance with automation and AI features
Expand business
How can teams scale compliance with a strategic approach?
Every new market and standard is an investment. The right compliance architecture compounds it across all of them; the wrong one means paying twice, and risking penalties in markets you entered underprepared.
How ins2outs helps
1-2 months
new market readiness
- Build integrated management system Quality, Information Security, AI, Privacy
- Multiple global markets ready out of the box with fractional expertise on demand
- Manage multiple products and streamline team collaboration
Optimize operations
How can teams consolidate and accelerate compliance processes?
Multiple tools and spreadsheets, no single source of truth. Every regulatory change means manual updates across disconnected systems. The larger the compliance scope, the more effort compounds, and the slower the response.
How ins2outs helps
2-5 days
to migrate from existing QMS for free
- Traceability, versioning and documentation lifecycle
- Compliance and product KPIs, automated onboarding and monitoring
- AI-powered automation eliminating effort-heavy tasks
How it works together
Everything you need to manage compliance in one place
Plug-in compliance knowledge
Know-how sets
Pre-built management systems — policies, procedures, role assignments, templates, and normative mappings — are available out of the box.
Integrated management system
The platform
Documentation, workflows, training, and evidence management in one system your whole team actually uses, configured around how you build.
Expertise on demand
Consulting services
Regulatory and compliance experts from Star available for everything from one-off setup calls to a full outsourced compliance function, scoped to what you need.
Most teams patch compliance together from tools, spreadsheets, and consultants that don’t talk to each other. ins2outs brings it into one system your whole team will actually use: a platform that runs it, content that makes it immediately usable, and expert support when you need it.
Integrated management system
Run compliance like you run the product
A continuous improvement loop that keeps your organisation and products compliant from first certification to long-term all-round compliance management.
How does ins2outs manage compliance for an organization?
INPUT
Regulations & standards
Market requirements
Normative sources
Define SOPs & policies
Assign roles & responsibilities
Manage access control
Control versions & traceability
Manage team work
Trace normative sources
Manage suppliers
OUTPUT
Audit evidence
Regulatory submissions
Certified quality records
How does ins2outs manage compliance for a product?
Product & risk profile
User requirements
INPUT
Idenitify safety, cybersecurity risks
Define product requirements
Trace product requirements
Audit findings
Post-market complaints
Regulatory updates
FEEDBACK
Plug-in compliance knowledge
One system. Any team size. Any compliance complexity.
Whether you’re three people chasing your first certification or 150 managing four domains across five markets, ins2outs runs the same way because it’s structured around how you build and ship instead of audits. Your roles, products, and processes sit at the center with standards and markets connecting to them.
What compliance domains does ins2outs support?
- Quality
- Information security
- AI
- Privacy
- Custom regulations
What global markets does ins2outs support for compliance?
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European Union
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United States
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United Kingdom
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Canada
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Australia
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Global markets
Expertise on-demand
We build and support regulated products. Leverage our acumen to bring your innovation to market faster.
Star is a global technology consultancy that designs, builds, and supports regulated products with certification — medical devices, AI systems, connected platforms. ins2outs exists because we needed it.
The same regulatory and product expertise that built the platform is available to your team, at any stage, as ad-hoc advisory, Manager-as-a-Service, or a full outsourced compliance function.
STRATEGY
How can teams get regulatory clarity with ins2outs?
Regulatory scoping, gap assessments, audits, and training that set the foundation.
IMPLEMENTATION
How can teams effectively use the ins2outs compliance platform?
Full compliance system setup — policies, roles, processes, training — configured on ins2outs.
MARKET PLACEMENT
How can ins2outs help teams open new markets for regulated products?
Regulatory scoping, gap assessments, audits, and training that set the foundation.
POST-MARKET
How can ins2outs help teams sustain and expand compliance efforts?
Regulatory scoping, gap assessments, audits, and training that set the foundation.
Hear from teams that moved faster with ins2outs
“The tool combines simplicity with powerful functionality, which perfectly matches our needs. The know-how set significantly reduced the time and effort needed to prepare our ISO 13485 Quality Management System, allowing our team to streamline processes effectively and pass the certification audit without any nonconformity.”