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Digital Product Compliance & Global Market Access

Our service helps to move from regulatory uncertainty to structured execution. Clearing the path for successful market entry.

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OUR SERVICES

Our Services to Build Trusted, Compliant Digital Solutions

Transforming regulatory complexity into practical actions that enable trusted digital innovation.

Strategy & Readiness

We provide structured regulatory assessments that clarify obligations and identify where organizations must take action. The outcome is a clear, prioritized plan for achieving regulatory compliance.

Align business objectives, target markets, and the regulatory strategy to establish a clear compliance direction.

Global Market Access Strategy

Determine whether your solution is in scope, classify its regulatory risk, and identify the applicable requirements.

Regulatory Applicability & Risk Classification

Identify compliance gaps, assess readiness, and prioritize actions based on business impact and regulatory risk.

Gap Analysis & Prioritization

Develop a practical, phased roadmap with prioritized actions to achieve regulatory compliance.

Compliance Roadmap

Remediation & Control Implementation

Design and implement the governance, processes, controls, and product practices needed to embed regulatory compliance across your organization.

Design governance structures, accountability models, and regulatory control frameworks that embed compliance across your organization.

Governance & Control Design

Develop policies, procedures, technical documentation, & evidence frameworks to support regulatory compliance & audit readiness.

Policies, Processes & Documentation

Integrate security, privacy, and regulatory requirements into product development through secure-by-design and compliance-by-design principles.

Secure & Compliant Product Design

Implement practical risk management processes and compliance tooling to manage obligations efficiently throughout the product lifecycle.

Risk Management & Compliance Tooling

Testing & Assurance

Validate compliance through testing, conformity assessments, and certification activities that provide objective evidence of regulatory compliance. Maintain regulatory compliance through continuous monitoring, lifecycle management, and proactive adaptation to evolving regulatory requirements.

Prepare for regulatory validation through compliance testing, evidence generation, and self-declaration activities where applicable.

Validation, Testing & Self-Declaration

Support conformity assessments, certification activities, and regulatory reviews to demonstrate compliance with confidence.

Conformity Assessment & Certification

Monitor regulatory developments, assess their impact, and maintain ongoing compliance across products and markets.

Regulatory Monitoring & Compliance

Manage regulatory change, continuously improve governance and controls, and maintain compliance throughout the entire product lifecycle.

Compliance Lifecycle Management
WHY CHOOSE NEMKO DIGITAL

The Value We Deliver

Get expert guidance, faster compliance, and market access

01.
Faster Compliance

Our proven methodology accelerates compliance. Most products achieve compliance readiness within 8-16 weeks.

02.
Competitive Advantage

Certified, compliant products build customer trust and create competitive differentiation in regulated markets.

03.
Market Access

Achieve certification and enter new markets with confidence. Our guidance covers EU, US, and Asia markets.

04.
Risk Reduction

Proactive compliance reduces legal, operational, and reputational risks associated with non-compliance.

05.
Expert Guidance

Our team includes regulatory experts, technical specialists, and certification professionals with deep EU regulatory knowledge.

06.
Scalable Approach

Our repeatable methodology applies across product types, regulations, and markets, making compliance scalable as you grow.

Move Faster. Stay Compliant.

Our proven compliance approach reduces risk and enables business growth.

See How it Works
WHY CHOOSE NEMKO DIGITAL

Digital Regulations Readiness Approach

Nemko offers a phased approach to interpret, remediate, validate, and continuously manage regulatory obligations; with a flexible support model.

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Discovery & Alignment

Compliance
Clarify the definition of done (detailed scope, standards and obligations).

Embedding
Build awareness and identify accountable owners.

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02

Discovery & Alignment

Compliance
Clarify the definition of done (detailed scope, standards and obligations).

Embedding
Build awareness and identify accountable owners.

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03

Discovery & Alignment

Compliance
Clarify the definition of done (detailed scope, standards and obligations).

Embedding
Build awareness and identify accountable owners.

03
04

Discovery & Alignment

Compliance
Clarify the definition of done (detailed scope, standards and obligations).

Embedding
Build awareness and identify accountable owners.

04
05

Discovery & Alignment

Compliance
Clarify the definition of done (detailed scope, standards and obligations).

Embedding
Build awareness and identify accountable owners.

05
06

Discovery & Alignment

Compliance
Clarify the definition of done (detailed scope, standards and obligations).

Embedding
Build awareness and identify accountable owners.

06

Ready to Move Forward?

Let's discuss how to accelerate compliance while reducing risk.

Schedule a Consultation
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WHY COMPLIANCE MATTERS

Regulatory Landscape for Digital Products

Digital products today must comply with multiple overlapping regulations. We help you navigate this complexity with expert guidance.

The regulatory landscape for digital products is rapidly evolving. The EU AI Act introduces new requirements for AI-enabled systems. GDPR protects personal data. The Cyber Resilience Act mandates security standards. The Data Act regulates data sharing. GPSR applies to connected and digital-enabled products.

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Multiple Regulations

Navigate overlapping EU regulations with expert guidance

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Competitive Advantage

Certified, compliant products build customer trust

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Market Access

Compliance is essential for entering EU and global markets

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Cost Savings

Avoid costly fines and remediation efforts

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Risk Management

Proactive compliance reduces legal and operational risks

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KEY REGULATIONS

Key Regulations Affecting Digital Products

Understanding which regulations apply to your product is the first step to compliance

EU AI Act

Applies to AI systems used in the EU. Classifies AI systems by risk level and requires compliance based on classification. Mandatory for high-risk AI systems.

Cyber Resilience Act (CRA)

Mandates cybersecurity standards for digital and connected products. Requires security testing, vulnerability management, and incident reporting.

Asian Regulations

Applies to digital-enabled products and connected devices. Requires safety assessment and compliance documentation

GDPR

Protects personal data processing. Applies to any product that collects or processes personal data. Requires privacy by design and data protection measures.

EU Data Act

Regulates data sharing and interoperability. Applies to products that generate or collect data. Requires data sharing mechanisms and portability.

US Regulations

ISO standards, industry-specific regulations, and emerging requirements may also apply depending on your product and market.

OUR IMPACT

Proven Results

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Countries where the AI-enabled service monitors appliance performance
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Repeatable model established for governing AI-driven services at scale
10-15%
Potential increase in sales performance from well- communicated trust marks
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Risk categories defined by the AI Trust Mark
REAL-WORLD EXAMPLE

AI Trust Mark: How Samsung Is Shaping the Future of Trusted
Connected Products

Samsung Electronics, the global leading manufacturer of consumer electronics and home appliances, was developing an advanced remote support system for connected home appliances. The system enables authorized technicians to remotely diagnose, troubleshoot, and resolve issues, significantly improving service efficiency while reducing the need for on-site interventions. By analysing operational data, the system can detect potential issues early, including equipment malfunctions, abnormal usage patterns, and maintenance needs.

Download the Full Case Study
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COMMON QUESTIONS

AI Systems Compliance FAQ

  • What services do we provide? 

      We provide end-to-end compliance and governance support for digital products and AI systems: Cyber & Data Foundations, Digital Product Regulatory Compliance & Market Access, AI Governance & ISO 42001 Certification, and AI Trust Mark Testing & Independent Assurance.

  • How do I define the scope of my digital product?

      Start by clearly stating who the product is for, list the core features it includes, and describe what it is used for. A clear scope makes it easier to identify which regulations apply.

  • What are the "no regret" steps I can take today?

      Define clear ownership within your organization, and put transparency, human oversight, and continuous monitoring in place. These create value regardless of how the regulatory landscape evolves.

  • Who is responsible within my enterprise?

      Responsibility is shared between provider and user, but it must always be clearly assigned. The product owner is responsible for intended use and performance; the user is responsible for following policies and safety guidelines.

  • Who are our ecosystem partners?

      IBM, Deeploy, [add remaining partners].

  • How do data, cyber, and AI intertwine?

      AI relies on high-quality data. Cybersecurity protects this data against misuse across its full lifecycle, while AI in turn strengthens cyber defenses by enabling faster threat detection.

  • What makes our approach unique?

      unique? Rather than treating cyber and data governance as separate disciplines, we integrate them into one unified trust and compliance approach.

  • What is the AI Trust Mark?

      The AI Trust Mark is a certification that signals a trustworthy AI system, helping customers quickly recognize that your system meets trust and compliance requirements.