IT Operations & Cybersecurity for Regulated Manufacturing

When IT operations, infrastructure, or cybersecurity become risks to business continuity or regulatory compliance, operational assessment and remediation are critical. Felaris Global evaluates and stabilizes IT operations with focus on FDA/MDR compliance requirements, business continuity, and audit readiness in regulated manufacturing environments.

Underperforming IT operations create business risk through system downtime, security vulnerabilities, and compliance gaps. We conduct operational assessments to identify risks and implement remediation plans that improve reliability, security, and regulatory compliance.

What you get: IT operational maturity assessment, infrastructure performance and capacity analysis, service delivery evaluation, incident and problem management review, vendor and support contract assessment, remediation roadmap and implementation

Medical device and regulated manufacturing companies face stringent cybersecurity requirements under FDA guidance, ISO 27001, and data protection regulations. We build cybersecurity programs that satisfy regulatory requirements while protecting business operations.

What you get: Cybersecurity risk assessment and gap analysis, security program design (policies, standards, procedures), access control and identity management frameworks, vulnerability management and patch management programs, security incident response planning, security awareness and training programs

Regulated environments require documented IT processes, change control, and governance frameworks to satisfy audit requirements. We establish IT governance aligned with FDA 21 CFR Part 11, ISO 13485, and ITIL best practices.

What you get: IT governance framework design, change management and release management processes, configuration management and asset tracking, IT risk management frameworks, service level management and KPI development, audit preparation and documentation

Legacy infrastructure creates performance bottlenecks, security risks, and compliance challenges. We optimize infrastructure and develop cloud migration strategies that improve scalability while maintaining regulatory compliance.

What you get: Infrastructure architecture assessment, cloud readiness evaluation and migration strategy, network architecture optimization, data center consolidation planning, backup and disaster recovery design, capacity planning and performance optimization

Multi-site, multi-country operations require coordinated IT service delivery, standardized processes, and 24/7 support capabilities. We design global IT service delivery models that balance centralization with local requirements.

What you get: Global service delivery model design, follow-the-sun support strategy, regional IT organization design, service desk and ITSM tool implementation, vendor consolidation and global contract management, cross-border data management and compliance

Regulatory requirements and business criticality demand tested business continuity and disaster recovery capabilities. We design and implement BC/DR programs that satisfy compliance requirements and protect business operations.

What you get: Business impact analysis and recovery objectives, disaster recovery strategy and architecture, backup and recovery testing protocols, business continuity plan development, crisis management and communication planning, regulatory compliance validation (FDA, ISO)

FDA Requirements: 21 CFR Part 11, cybersecurity guidance for medical devices

ISO Standards: ISO 27001 (Information Security), ISO 13485 (Quality Management System), ISO 22301 (Business Continuity)

Data Protection: GDPR, data residency and sovereignty requirements

Industry Frameworks: NIST Cybersecurity Framework, ITIL service management

Medical device manufacturing, pharmaceutical and life sciences, regulated manufacturing, warehouse/distribution, industrial manufacturing, growth-stage companies