Introduction

Kenya’s healthcare sector is undergoing rapid transformation with increased investment in medical technology manufacturing, digital health innovation, and cross-border medical device trade. As regulatory oversight strengthens, medical device companies must demonstrate full lifecycle compliance—from design and import readiness to post-market performance and cybersecurity assurance.

Cyberintelsys provides end-to-end medical devices regulatory compliance assessment services in Kenya, enabling manufacturers, importers, and digital health innovators to meet evolving Pharmacy and Poisons Board (PPB) expectations while integrating CREST-aligned cybersecurity validation for modern, connected medical devices.

Evolving Medical Device Regulation in Kenya

Kenya regulates medical devices through the Pharmacy and Poisons Board (PPB), with a growing focus on:

• Risk-based device classification

• Technical documentation completeness

• Safety and performance verification

• Software reliability and cybersecurity resilience

• Continuous post-market compliance

As Kenya positions itself as a regional healthcare and medtech gateway for East Africa, regulators increasingly expect alignment with international regulatory and quality frameworks, especially for imported and software-driven devices.

Why End-to-End Compliance Matters Today

Traditional, fragmented compliance approaches no longer work. Regulatory approval, cybersecurity, software governance, and quality systems are now interconnected.

Key drivers for end-to-end compliance in Kenya include:

• Growth of connected and cloud-enabled medical devices

• Expansion of telemedicine and remote diagnostics

• Increased regulatory attention to cyber incidents in healthcare

• Demand for traceability, audit readiness, and lifecycle risk management

Cyberintelsys addresses these demands through a unified compliance assessment model.

Cyberintelsys End-to-End Compliance Framework

1. Market Entry & Regulatory Pathway Assessment

Cyberintelsys begins with a structured evaluation of:

• Device classification and approval routes

• Importer, distributor, and local representation obligations

• Regulatory submission readiness

• Product-specific compliance risks

This phase reduces regulatory uncertainty and prevents costly submission delays.

2. Technical Documentation & Quality Alignment

We assess and optimize core compliance documentation, including:

• Technical files and device master records

• Risk management and usability engineering evidence

• Clinical performance and safety documentation

• Labeling and instructions for use compliance

This ensures documentation aligns with PPB expectations and international best practices.

3. Software & Digital Health Compliance Assessment

For devices with embedded software or standalone digital solutions, Cyberintelsys evaluates:

• Software lifecycle governance

• Version control and change impact analysis

• System reliability and failure management

• Interoperability and data integrity controls

This is critical for software-intensive and AI-enabled medical devices entering the Kenyan market.

4. CREST-Aligned Cybersecurity Assurance

Cybersecurity has become a defining factor in medical device compliance. Cyberintelsys delivers:

• Security architecture and design reviews

• Threat modeling tailored to healthcare environments

• CREST-aligned penetration testing

• Vulnerability management and remediation planning

• Secure update and patch management assessments

CREST-aligned testing provides trusted, regulator-ready cybersecurity assurance.

5. Data Protection & Patient Safety Controls

Medical devices handling health data must ensure:

• Secure data collection and processing

• Access control and audit logging

• Protection against data loss and unauthorized access

• Alignment with Kenya’s Data Protection Act

Cyberintelsys integrates privacy-by-design and safety-by-design principles into compliance assessments.

6. Post-Market Surveillance & Continuous Compliance

Regulatory compliance extends beyond approval. Our services include:

• Post-market performance monitoring

• Cyber risk reassessment after updates or changes

• Incident response and regulatory reporting readiness

• Audit and inspection preparation support

This ensures sustained compliance throughout the device lifecycle.

What Makes Cyberintelsys Different?

• True end-to-end compliance coverage

• Integrated regulatory, software, and cybersecurity expertise

• CREST-aligned security validation for healthcare technologies

• Practical, implementation-focused guidance

• Reduced regulatory risk and faster market confidence

Cyberintelsys acts as a strategic compliance partner, not just an assessor.

Business Benefits of End-to-End Compliance

• Faster regulatory approvals in Kenya

• Lower risk of non-compliance and recalls

• Stronger cybersecurity and patient safety posture

• Improved trust with regulators and healthcare providers

• Long-term operational resilience

Conclusion

As Kenya advances toward a digitally enabled healthcare ecosystem, medical device companies must adopt a holistic compliance strategy that addresses regulation, software governance, cybersecurity, and post-market accountability together.

Cyberintelsys end-to-end medical devices regulatory compliance assessment services in Kenya, strengthened by CREST-aligned cybersecurity assurance, help organizations confidently deliver safe, compliant, and future-ready medical technologies to the Kenyan market.