ins2outs –
integrated AI-powered Compliance Management System

Simplify compliance, amplify growth.

Why teams choose ins2outs?

From startups to enterprises, ins2outs makes compliance simple, scalable, and cost-effective — without the burden of manual processes.

Cut setup time by 75% with pre-built know-how sets.

Audit-ready in 6 months for QMS, ISMS, AI governance, and more.

One platform, multiple standards & cross market requirements — ISO, FDA, MDR, IVDR.

Real-time compliance tracking with automated mapping.

Key Features – built for Compliance Leaders

All your compliance tasks, documents, and training — integrated and automated in one secure platform.

✓ Multi-System Management

Manage QMS, ISMS, AI Management System compliance with shared SOPs in one system without duplication

See how it works

✓ Intelligent Automation

Auto-tasks for reviews, approvals, signatures and training - CFR 820-compliant.

✓ Role-Based Access & training

Assign roles with clear responsibilities and instant onboarding and training to keep your team audit-ready

✓ AI Assistant

Create, summarize, review and identify gaps in your documents in seconds

✓ Normative Mapping & Compliance tracking

Map all documents to normative sources, track readiness and compliance.

AI features roadmap

We’re progressively embedding AI across our compliance platform, starting with risk mapping and literature search today, followed by triage, template checks, and full validation.

Pre-built know-how sets and SOPs

ins2outs provides ready-to-use frameworks that cut months off implementation time.

Choose Your Know-How Set

ISO 13485 + 21 CFR 820
Price: € 6,500 / set

Consulting services

Our experts act as an extension of your team — guiding you through every step of compliance and certification.

8 years of trusted Compliance Excellence

Smooth Path to Certification

“Thanks to ins2outs, we were able to pass the certification audit without any nonconformity, ensuring a smooth, stress-free experience. The provided know-how package significantly reduced the time and effort needed to prepare our ISO 13485 QMS, allowing our team to streamline processes effectively.

Paweł

Lead Quality and Regulatory Affairs Engineer

Quality Made Easy

“We migrated from another eQMS and found ins2outs remarkably easy to adapt. Its flexibility and user-friendly design seamlessly support our evolving needs, helping us maintain high standards with ease and confidence, making a real difference in our day-to-day quality management.”

Anette

Quality and Administration Manager

Strategic Approach and Implementation

“Star's expertise has been invaluable in helping us achieve
MDR compliance. Their strategic approach streamlined our processes without disrupting our operations. With their guidance, we're now positioned to scale confidently into new markets.”

Borut Stavrov

CTO

Quick Time to Market

“Time-to-market is one of the decisive factors for any startup. Star’s team and their complete QMS offering, including QMaaS, gave us a huge headstart on our quality and regulatory compliance.
The success gMendel has experienced would not be possible without Star's contribution.”

Zoran Velkoski

Co-founder

Rapid QMS Implementation

“Overall my experience has been extremely positive with ins2outs compared with other QMS's. We switched to ins2outs from Greenlight Guru. Star regulatory team implemented a robust QMS compliant with five market regulatory requirements, and work as part of our team.”

Julia Ross

Technical Product Manager

Global Market Access

“Star's expertise in quality and regulatory compliance has been key to overcoming complex challenges and bringing innovations to market. Agata's precision and dedication give us confidence to expand globally while staying compliant with evolving regulations.”