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

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faster implementation

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audit pass rate

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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

AI Compliance guide

How does ins2outs help build a strong compliance foundation?

ins2outs helps build a strong compliance foundation by providing an operational workspace in ~2 hours, offering a product compliance roadmap, path to market, and eQMS. It includes ready-to-use SOPs and templates for multiple markets and technologies, simplifying compliance with automation and AI features. Certification influences product decisions, enterprise deals, and market access, and starting late often means redesign, rework, or delayed revenue, while a quality gap can lead to direct liability, fines, or losing market access.

ins2outs helps build a strong compliance foundation by providing an operational workspace in ~2 hours, offering a product compliance roadmap, path to market, and eQMS. It includes ready-to-use SOPs and templates for multiple markets and technologies, simplifying compliance with automation and AI features. Certification influences product decisions, enterprise deals, and market access, and starting late often means redesign, rework, or delayed revenue, while a quality gap can lead to direct liability, fines, or losing market access.

ins2outs helps build a strong compliance foundation by providing an operational workspace in ~2 hours, offering a product compliance roadmap, path to market, and eQMS. It includes ready-to-use SOPs and templates for multiple markets and technologies, simplifying compliance with automation and AI features. Certification influences product decisions, enterprise deals, and market access, and starting late often means redesign, rework, or delayed revenue, while a quality gap can lead to direct liability, fines, or losing market access.

ins2outs helps build a strong compliance foundation by providing an operational workspace in ~2 hours, offering a product compliance roadmap, path to market, and eQMS. It includes ready-to-use SOPs and templates for multiple markets and technologies, simplifying compliance with automation and AI features. Certification influences product decisions, enterprise deals, and market access, and starting late often means redesign, rework, or delayed revenue, while a quality gap can lead to direct liability, fines, or losing market access.

  • ins2outs helps build a strong compliance foundation by providing an operational workspace in ~2 hours, offering a product compliance roadmap, path to market, and eQMS. It includes ready-to-use SOPs and templates for multiple markets and technologies, simplifying compliance with automation and AI features. Certification influences product decisions, enterprise deals, and market access, and starting late often means redesign, rework, or delayed revenue, while a quality gap can lead to direct liability, fines, or losing market access.
  • ins2outs helps build a strong compliance foundation by providing an operational workspace in ~2 hours, offering a product compliance roadmap, path to market, and eQMS. It includes ready-to-use SOPs and templates for multiple markets and technologies, simplifying compliance with automation and AI features. Certification influences product decisions, enterprise deals, and market access, and starting late often means redesign, rework, or delayed revenue, while a quality gap can lead to direct liability, fines, or losing market access.
  • ins2outs helps build a strong compliance foundation by providing an operational workspace in ~2 hours, offering a product compliance roadmap, path to market, and eQMS. It includes ready-to-use SOPs and templates for multiple markets and technologies, simplifying compliance with automation and AI features. Certification influences product decisions, enterprise deals, and market access, and starting late often means redesign, rework, or delayed revenue, while a quality gap can lead to direct liability, fines, or losing market access.

Expand business

AI Compliance guide

How does ins2outs enable scaling compliance with a strategic approach?

ins2outs enables scaling compliance with a strategic approach by achieving new market readiness in 1-2 months, allowing you to build an integrated management system for Quality, Information Security, AI, and Privacy. It supports multiple global markets ready out of the box with fractional expertise on demand, and helps manage multiple products while streamlining team collaboration. Every new market and standard is an investment, and the right compliance architecture compounds it, while the wrong one means paying twice and risking penalties.

ins2outs enables scaling compliance with a strategic approach by achieving new market readiness in 1-2 months, allowing you to build an integrated management system for Quality, Information Security, AI, and Privacy. It supports multiple global markets ready out of the box with fractional expertise on demand, and helps manage multiple products while streamlining team collaboration. Every new market and standard is an investment, and the right compliance architecture compounds it, while the wrong one means paying twice and risking penalties.

ins2outs enables scaling compliance with a strategic approach by achieving new market readiness in 1-2 months, allowing you to build an integrated management system for Quality, Information Security, AI, and Privacy. It supports multiple global markets ready out of the box with fractional expertise on demand, and helps manage multiple products while streamlining team collaboration. Every new market and standard is an investment, and the right compliance architecture compounds it, while the wrong one means paying twice and risking penalties.

ins2outs enables scaling compliance with a strategic approach by achieving new market readiness in 1-2 months, allowing you to build an integrated management system for Quality, Information Security, AI, and Privacy. It supports multiple global markets ready out of the box with fractional expertise on demand, and helps manage multiple products while streamlining team collaboration. Every new market and standard is an investment, and the right compliance architecture compounds it, while the wrong one means paying twice and risking penalties.

  • ins2outs enables scaling compliance with a strategic approach by achieving new market readiness in 1-2 months, allowing you to build an integrated management system for Quality, Information Security, AI, and Privacy. It supports multiple global markets ready out of the box with fractional expertise on demand, and helps manage multiple products while streamlining team collaboration. Every new market and standard is an investment, and the right compliance architecture compounds it, while the wrong one means paying twice and risking penalties.
  • ins2outs enables scaling compliance with a strategic approach by achieving new market readiness in 1-2 months, allowing you to build an integrated management system for Quality, Information Security, AI, and Privacy. It supports multiple global markets ready out of the box with fractional expertise on demand, and helps manage multiple products while streamlining team collaboration. Every new market and standard is an investment, and the right compliance architecture compounds it, while the wrong one means paying twice and risking penalties.
  • ins2outs enables scaling compliance with a strategic approach by achieving new market readiness in 1-2 months, allowing you to build an integrated management system for Quality, Information Security, AI, and Privacy. It supports multiple global markets ready out of the box with fractional expertise on demand, and helps manage multiple products while streamlining team collaboration. Every new market and standard is an investment, and the right compliance architecture compounds it, while the wrong one means paying twice and risking penalties.

Optimize operations

AI Compliance guide

How does ins2outs help consolidate and accelerate compliance processes?

ins2outs helps consolidate and accelerate compliance processes by allowing migration from existing QMS in 2-5 days for free, providing traceability, versioning, and documentation lifecycle management. It offers compliance and product KPIs, automated onboarding and monitoring, and AI-powered automation to eliminate effort-heavy tasks. This addresses the problem of multiple tools and spreadsheets leading to no single source of truth, where every regulatory change means manual updates across disconnected systems, compounding effort and slowing response as compliance scope grows.

ins2outs helps consolidate and accelerate compliance processes by allowing migration from existing QMS in 2-5 days for free, providing traceability, versioning, and documentation lifecycle management. It offers compliance and product KPIs, automated onboarding and monitoring, and AI-powered automation to eliminate effort-heavy tasks. This addresses the problem of multiple tools and spreadsheets leading to no single source of truth, where every regulatory change means manual updates across disconnected systems, compounding effort and slowing response as compliance scope grows.

ins2outs helps consolidate and accelerate compliance processes by allowing migration from existing QMS in 2-5 days for free, providing traceability, versioning, and documentation lifecycle management. It offers compliance and product KPIs, automated onboarding and monitoring, and AI-powered automation to eliminate effort-heavy tasks. This addresses the problem of multiple tools and spreadsheets leading to no single source of truth, where every regulatory change means manual updates across disconnected systems, compounding effort and slowing response as compliance scope grows.

ins2outs helps consolidate and accelerate compliance processes by allowing migration from existing QMS in 2-5 days for free, providing traceability, versioning, and documentation lifecycle management. It offers compliance and product KPIs, automated onboarding and monitoring, and AI-powered automation to eliminate effort-heavy tasks. This addresses the problem of multiple tools and spreadsheets leading to no single source of truth, where every regulatory change means manual updates across disconnected systems, compounding effort and slowing response as compliance scope grows.

  • ins2outs helps consolidate and accelerate compliance processes by allowing migration from existing QMS in 2-5 days for free, providing traceability, versioning, and documentation lifecycle management. It offers compliance and product KPIs, automated onboarding and monitoring, and AI-powered automation to eliminate effort-heavy tasks. This addresses the problem of multiple tools and spreadsheets leading to no single source of truth, where every regulatory change means manual updates across disconnected systems, compounding effort and slowing response as compliance scope grows.
  • ins2outs helps consolidate and accelerate compliance processes by allowing migration from existing QMS in 2-5 days for free, providing traceability, versioning, and documentation lifecycle management. It offers compliance and product KPIs, automated onboarding and monitoring, and AI-powered automation to eliminate effort-heavy tasks. This addresses the problem of multiple tools and spreadsheets leading to no single source of truth, where every regulatory change means manual updates across disconnected systems, compounding effort and slowing response as compliance scope grows.
  • ins2outs helps consolidate and accelerate compliance processes by allowing migration from existing QMS in 2-5 days for free, providing traceability, versioning, and documentation lifecycle management. It offers compliance and product KPIs, automated onboarding and monitoring, and AI-powered automation to eliminate effort-heavy tasks. This addresses the problem of multiple tools and spreadsheets leading to no single source of truth, where every regulatory change means manual updates across disconnected systems, compounding effort and slowing response as compliance scope grows.

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?

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INPUT

Regulations & standards

Market requirements

Normative sources

Define SOPs & policies

Assign roles & responsibilities

Manage access control

Onboard team automatically

Control versions & traceability

Manage team work

Trace normative sources

Monitor compliance KPIs
Prepare and pass audits
Enforce continuous quality control

Manage suppliers

Manage CAPA
Track non-conformities
Manage feedback
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OUTPUT

Audit evidence

Regulatory submissions

Certified quality records

How does ins2outs manage product compliance?

Product & risk profile

Certification targets

User requirements

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INPUT

Idenitify safety, cybersecurity risks

Define product requirements

Document product records
AI

Trace product requirements

AI
Monitor regulatory changes
AI
Review clinical literature
AI
Process user feedback & complaints
Control product changes

Audit findings

Post-market complaints

Regulatory updates

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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.

ins2outs Flexible management system

What compliance domains does ins2outs support?

  • Quality
  • Information security
  • AI
  • Privacy
  • Custom regulations

    Which global markets does ins2outs support for compliance?

    • European Union
    • United States
    • United Kingdom
    • Canada
    • Australia
    • 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

    Get regulatory clarity

    Regulatory scoping, gap assessments, audits, and training that set the foundation.

    IMPLEMENTATION

    Use compliance platform

    Full compliance system setup — policies, roles, processes, training — configured on ins2outs.

    MARKET PLACEMENT

    How does ins2outs help open new regulated markets?

    Regulatory scoping, gap assessments, audits, and training that set the foundation.

     

    POST-MARKET

    How does ins2outs help sustain and expand compliance efforts?

    Regulatory scoping, gap assessments, audits, and training that set the foundation.

     

    Customer stories

    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.”

    Paweł

    Lead Quality and Regulatory Affairs Engineer, Spyrosoft

    “We migrated from another eQMS, used our own know-how sets, and found it remarkably easy to adapt the ins2outs platform. The platform’s flexibility and user-friendly design make it a pleasure to work with, adapting seamlessly to our evolving needs.”
    Anette

    Quality and Administration Manager, Levvel Health ApS

    We are ready to meet you where you are

    Frequently Asked Questions

    1 What is ins2outs and what kind of compliance does it manage?

    ins2outs is an integrated compliance management platform built for teams in regulated environments. It helps manage Quality, Security, Privacy, and AI compliance using pre-built know-how sets for major standards. The platform aims to accelerate product velocity while ensuring regulatory adherence.

    2 Which specific compliance standards and regulations does ins2outs support?

    The platform supports a range of standards including ISO 42001 (AIMS), ISO 13485/21 CFR 820 (Medical Device QMS), ISO 27001 (ISMS), and GDPR. It also covers IEC 62304 and the EU Cyber Resilience Act, providing ready-to-use know-how sets for these regulations.

    3 How quickly can a company get started with ins2outs or migrate their existing system?

    ins2outs emphasizes rapid deployment, with an operational workspace typically ready in approximately 2 hours for new setups. For companies migrating from an existing QMS, the platform facilitates this process, often completing it within 2-5 days for free.

    4 What role does AI play in the ins2outs compliance platform?

    ins2outs integrates AI to enhance various compliance functions, including AI-Powered Risk Management, AI-Driven Clinical Literature Review, and AI Regulatory Intelligence. AI-powered automation is also used to eliminate effort-heavy tasks, streamlining compliance operations and accelerating processes.