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.
✓ 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 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.
Risk File Generation
AI maps risks based on device purpose and specs —
fast, structured, aligned with standardsPrecision risk calibration for confident compliance:
✓ Probability & Severity Scales
✓ Risk Acceptance Criteria
✓ Dynamic Risk Score Matrix
✓ Full Audit Traceability
AI-Driven Literature Search
Pulls relevant studies from PubMed, flags gaps, and surfaces insights to support CER
Automate and accelerate the process of gathering, analyzing, and justifying scientific literature to support your product development, regulatory submissions, and post-market surveillance.
✓ Describe your medical device
✓ Run AI literature search & analysis
✓ Get your report
Complaint Triage
Auto-categorizes complaints by urgency and context, recommends fixes using past data
Coming soon
CSOP Validation
Compares procedural steps to SOPs, flags deviations, and ensures hierarchy compliance
Coming soon
Template Checks
Verifies structure, catches missing or ambiguous content, and enforces guideline alignment
Coming soon
Pre-built know-how sets and SOPs
ins2outs provides ready-to-use frameworks that cut months off implementation time.
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.
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.”
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.”
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.”
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.”
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.”
Compare & Win with ins2outs
Side-by-side, ins2outs delivers more speed, flexibility, and value than traditional compliance tools.
Pricing Made Simple
No surprises. Just clear, scalable plans that grow with your business.
