Compliance Management Platform · QMS · AIMS · ISMS · PIMS

One platform for every compliance requirement your team has to meet

Every other compliance tool is built around a certification. ins2outs Compliance Management Platform is built around your organisation: how it defines, operates, and proves itself.

Compliance Management Platform

4

Management systems in one

100+

Audits passed in 2025

100%

Clients stay 3+ years

9/10

NPS score

How ins2outs Compliance Management Platform is different

Connecting the product lifecycle to the regulatory world your organization operates in

Building a regulated product means managing market requirements, organisational compliance, and product development simultaneously.

ins2outs connects all three, so evidence is produced where work happens, requirements stay linked to the decisions they drive, and nothing has to be reconstructed when an auditor asks.

ins2outs — How it works
Market
Organisation
Product
Inputs
Regulatory requirements
Applicable standards
Market rules
User feedback
Complaints & incidents
Post-market surveillance
Governance decisions
Management review outcomes
Policy requirements
Team structure & roles
Supplier relationships
Design inputs
SDLC artefacts
Test results
Change requests
Risk assessments
ins2outs

Requirements become normative sources. Complaints enter as traceable records. Documentation readiness tracks against every clause.

Policies map to standards. Roles carry responsibilities and awareness obligations. Review outcomes generate actions automatically.

Design controls, risk records, and change requests sit alongside the management system that governs them. Every product decision is traceable.

Outputs
Audit documentation
Technical files
Conformity assessments
Regulatory submissions
Incident reports
Compliance KPIs
Training records
Management review reports
Nonconformity logs
Corrective actions
Design history files
Risk management files
Software documentation
CAPA actions

Compliance Management Platform capabilities

Your integrated compliance management platform, instead of a document folder

Most compliance management platforms have an opinion about how your team should work. ins2outs gives you the structure that reflects how your organisation actually works: it allows you to define what kind of work and how it gets done, who is responsible, what evidence is produced, and how all of it maps to the standards you’re certified against.

You can use our Know-How Sets, pre-built management systems built by practitioners, covering the policies, processes, procedures, and roles a compliant organisation needs for each standard. Your team decides what to adopt, what to adapt, and what to leave out. The platform holds whatever you build, in the shape you build it.

Define how your organisation operates

Know-How sets

Leverage policies, processes, procedures, roles, and document templates, each mapped to the normative clause it satisfies.

See your compliance coverage

Normative Sources

Every policy, process, and record links to the clause it satisfies, showing what your system produces against standards.

Move work through the system

Tasks & workflows

Role assignments generate awareness tasks, document changes route to reviewers, and checkups recur on your cadence.

Produce traceable evidence as work happens

Documents & records

Product docs, audit records, nonconformities, and CAPAs are version-controlled and linked to the normative source.

Trace product requirements at every stage

Traceability matrices

Requirements link to the design controls, risk records, test results, and docs from initial design through to final testing.

Delegate the effort-heavy work to AI

AI automation

Accelerate generating risk files, searching and appraising clinical literature, and monitoring regulatory changes with AI.

Give every role a compliance starting point

Roles Management

Roles generate a list of responsibilities and RACI assignments for their compliance onboarding.

Keep your team trained, aware, and audit-ready

Education

Role assignments generate training tasks automatically and completion tracks per person, per role, per normative source.

Quality compliance automation powered by AI

AI modules inside the ins2outs Compliance Management Platform take on the repetitive, high-volume compliance work for your team. Each module connects to your product scope and target markets, runs continuously, and delivers results inside the same system where your quality processes live.

Generate, review, and maintain risk files for every product your team builds. Describe your device, define your hazards, and receive a structured risk file — safety, cybersecurity, and process risks in one register, connected to your documentation. 75% time saving on initial generation.

Explore AI Risk Management ->

Automate the process of gathering, analysing, and scoring clinical literature to support product development, regulatory submissions, and post-market surveillance. Describe your medical device, run the search against PubMed, and receive a scored, justified report in minutes.

Explore AI Clinical Literature Review ->

Monitor regulatory changes across your target markets automatically. Track updates to standards, guidelines, and enforcement actions that affect your products. Get alerted when something changes so your team can assess impact and update procedures before the next audit.

Explore AI Regulatory Intelligence ->

AI regulatory intelligence

 

Integrations

The connective tissue of your product stack

ins2outs Compliance Management Platform connects to the tools product teams use so that product planning, development, testing, and sign-off all feed into one system, traceable, auditable, and ready for any standard your product is subject to.

Explore how integrations turn ins2outs into a central hub for compliance product lifecycle management ->

Link product work to compliance requirements

Connect Jira or ClickUp and tie issues, epics, and releases to design controls, risk records, and change requests. Every product decision has a record in the system.

ins2outs jira integration
ins2outs clickup integration

Carry compliance context through product lifecycle

GitHub and GitLab integrations connect code changes to document control and change management workflows. Software releases carry their compliance context.

ins2outs github integration
ins2outs gitlab integration

Keep the whole product team in the loop

Slack and Microsoft Teams deliver task notifications, review requests, and sign-off alerts where the team already communicates. Product and compliance work in the same conversation.

ins2outs slack integration
ins2outs ms teams integration

Sign in and sign off with one set of credentials

Google SSO and Microsoft SSO connect your identity across the stack. Electronic signatures for documents and tasks use the same login — no separate account, CFR Part 11 compliant.

ins2outs sso integration

Pull in evidence from across the stack

TestRail integration brings existing test records into ins2outs records. The audit trail is continuous and consistent, even for evidence that originates outside the platform.

ins2outs testrail integration
ins2outs off-the-shelf compliance solutions

Plug-and-play regulatory expertise for four compliance domains

Most regulated product teams are subject to more than one standard. A medical SaaS product might need ISO 13485, ISO 27001, ISO 42001, and GDPR simultaneously. The standard response is four separate tools, four separate evidence sets, and duplicated controls.

With ins2outs, you can run one domain or all four in a single connected system: shared controls, shared evidence, one audit trail without duplicating the work when standards overlap.

ins2outs — Solutions Venn
ins2outs Compliance Management Platform

Platform pricing

*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.

 

Ready to see ins2outs in your context?

Request a free demo and we’ll walk through the platform with your compliance context: the standards you’re working to, the markets you’re targeting, and the team you have.