by Maksym Tsivyna
Regulatory compliance services
Turning compliance into strategic asset
We provide end-to-end regulatory support across the entire product lifecycle, from early-stage development to successful market access.
Guiding you from regulatory scoping to post-market surveillance
From early ideas to long-running systems, we help regulated companies replace scattered compliance work with a streamlined, proactive system that accelerates market entry and creates a foundation for future innovation.
Regulatory scoping that informs product decisions
You get early regulatory clarity to guide product and platform decisions, and a clear regulatory pathway that reduces risk and supports faster market entry.
Define regulatory strategy for your medical device, AI product or information security
Conduct gap assessment, due diligence and internal audits
Train and upskill your organization for compliance maturity
Enterprise compliance platform that keeps pace with your innovation
ins2outs is a unified platform for Quality, Security, Privacy, and AI compliance, built to support multi-product, multi-market organizations without fragmenting systems or slowing roadmaps.
3 months
QMS Definition
1. Set up
Applicable QMS regulations and standards are scoped, and core quality processes (document control, CAPA, risk management) are defined.
2. Customize
The QMS is mapped to your organization, products and services, with procedures, roles, responsibilities and quality objectives aligned.
3 months
QMS Implementation and Compliance
3. Share
The QMS is introduced to teams and process owners through role-based training and embedded into operational quality processes.
4. Certify
External audit preparation and support are provided, certification is achieved, and nonconformities and CAPAs are resolved.
ongoing support
Future Options
5. Improve
The QMS operates as a living system, with performance monitored and continuous improvement supported over time.
3 months
AIMS Definition
1. Get know-how
Applicable AI regulations, standards, and frameworks are scoped, and the AI system lifecycle and core governance processes are defined.
2. Customize
The AIMS is mapped to your product, models, and platform, with AI policies, controls and accountability aligned to real AI risks and use cases.
3 months
AIMS Implementation and Compliance
3. Share
The AIMS is introduced to product, engineering and data teams through role-based AI governance and risk training, and embedded into operations.
4. Certify
Preparation for external audit or regulatory assessment is completed, with AI evidence, documentation, and corrective actions reviewed and finalized.
ongoing support
Future Options
5. Improve
The AIMS operates as a living system, with AI performance, risks and compliance continuously monitored and updated over time.
3 months
ISMS Definition
1. Get know-how
Information security requirements are scoped with information assets, data flows, and core security processes defined.
2. Customize
The ISMS is tailored to your systems, data flows and risks, with security policies, controls and governance roles aligned to threats.
3 months
ISMS Implementation and Compliance
3. Share
The ISMS is rolled out to teams through role-based training, and security workflows are embedded into daily operations.
4. Certify
Audit readiness is supported through evidence alignment, targeted tracking, and closure of gaps and corrective actions.
ongoing support
Future Options
5. Improve
The ISMS operates with security performance, risks, and controls monitored and refined based on real usage data.
3 months
QMS Definition
1. Set up
Applicable QMS regulations and standards are scoped, and core quality processes (document control, CAPA, risk management) are defined.
2. Customize
The QMS is mapped to your organization, products and services, with procedures, roles, responsibilities and quality objectives aligned.
3 months
QMS Implementation and Compliance
3. Share
The QMS is introduced to teams and process owners through role-based training and embedded into operational quality processes.
4. Certify
External audit preparation and support are provided, certification is achieved, and nonconformities and CAPAs are resolved.
ongoing support
Future Options
5. Improve
The QMS operates as a living system, with performance monitored and continuous improvement supported over time.
Enterprise-grade frameworks, startup-speed deployment
Deploy additional management systems when M&A, market expansion, or product innovation demands it. Know-How Sets for Quality, Security, Privacy, and AI integrate seamlessly with your existing compliance infrastructure.
Quality Management
ISO 13485
IEC 62304
ISO 14971
ISO 9001
MDR, IVDR
FDA
Artificial Intelligence
ISO 42001
EU AI Act
ISO 23894
Information Security
ISO 27001
ISO 27002
SOC 2
Data Privacy
ISO 27701
GDPR
HIPAA
Get your product on the market with local support and conformity confidence
Bringing a regulated product to market often requires more than just certification: you need the right representation in target jurisdictions, support through conformity assessment activities, and accountability for ongoing regulatory obligations.
In-country representation
Authorized regulatory contact with local authorities without establishing a legal entity.
Conformity assessment
End-to-end support for submissions, notified body interactions, and assessment queries.
PRRC enablement
Operational PRRC function with regulatory accountability and compliance management.
Maintain compliance
Keep systems operational for post-market obligations, updates, and regulatory alignment.
Expand to new markets
Extend existing compliance foundations to support expansion into new regions and regulatory requirements.
Launch new products
Bring products to market faster by reusing established compliance infrastructure.
Global experience you can rely on
Whether you’re entering the EU, the US, or expanding into Asia-Pacific, we bring hands-on experience with local authorities, notified bodies, and medical device regulators, so your compliance journey moves faster and with fewer surprises.
Compliance solutions tailored to your industry
Every regulated sector faces its own pressures, standards, and expectations. We combine industry expertise with ready-to-use frameworks to help you meet requirements faster, operate with confidence and scale without friction.
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Healthcare & Life Sciences
Compliance support for medical devices, digital health and AI-driven diagnostics
We streamline regulatory strategy, documentation, software lifecycle compliance and post-market processes to help you meet global compliance standards like ISO 13485 and market regulators (EU MDR/IVDR, FDA, TGA, MHRA, etc.), accelerate approvals, strengthen patient safety, and maintain audit readiness across global markets.
Automotive & Mobility
Quality and compliance foundations for complex automotive software and systems
Deliver safer, more reliable systems with ASPICE-aligned processes and emerging AI governance.
From functional safety basics to compliance-ready SDLC workflows and integrated QMS/ISMS, we support teams building complex vehicle and mobility solutions under rapidly evolving industry standards.Media & Advertising
Governance and compliance for AI-enabled content, data and campaign ecosystems
Keep pace with tightening AI rules, privacy expectations and content integrity standards through governance models designed for fast-moving creative and data-driven environments without slowing campaign momentum.
Our impact
Delivering results in complex regulatory environments
Explore real examples of how companies across regulated industries built stronger systems, accelerated approvals and improved product reliability with our support.
Scaling SaMD Solutions: Heart for Health’s Journey to MDR Compliance
Discover how strategic compliance turned into a launchpad for international expansion.
Helping Brain Stimulation AB lead safe innovation through regulatory change
Explore Brain Stimulation’s path to regulatory success.
Scaling SaMD Solutions: Heart for Health’s Journey to MDR Compliance
Discover how strategic compliance turned into a launchpad for international expansion.
Helping Brain Stimulation AB lead safe innovation through regulatory change
Explore Brain Stimulation’s path to regulatory success.
Streamlining gMendel’s regulatory journey to deliver innovative MedTech solutions
With Star HealthTech’s regulatory consulting, gMendel got their life-changing genetic screening platform to market sooner. See how we streamline regulated MedTech product development, solve challenges and create foundations for growth.
Actionable insights
Expert perspectives on driving product velocity through compliance
We translate complex regulatory requirements into practical guidance that helps product teams move faster with confidence.
Connect with our experts
Bring us your goals, we’ll help you clarify the opportunity, reduce risk, and chart a practical path from ambition to execution.
