Regulatory Standards Expertise

When regulatory compliance is slowing product development or blocking system upgrades, you need validation frameworks that satisfy auditors without creating bottlenecks. Felaris provides compliance advisory and Virtual Chief Compliance Officer services for medical device and IVD companies across the US, Caribbean, and Europe, navigating FDA 21 CFR Part 11, ISO 13485, ISO 27001, EU MDR, and IVDR requirements.

Enterprise systems in regulated environments require validation that satisfies FDA Part 11 and EU MDR audit expectations. Felaris provides CSV consulting for ERP, quality management systems, and manufacturing execution systems: validation strategy and risk assessment, protocol development (IQ, OQ, PQ), testing and documentation, audit trail configuration, and change control.

Building or upgrading QMS platforms requires alignment between quality, IT, and regulatory functions. We guide QMS implementation and eQMS platform deployment to ensure systems meet ISO 13485 and FDA requirements while supporting operational efficiency.

Implementing a new ERP or QMS? Our ERP Strategy and Advisory team works alongside our compliance practice to ensure your systems are validated from day one. 

Preparing for FDA inspections or EU MDR compliance audits requires documented processes, validated systems, and cross-functional alignment. We develop compliance roadmaps and remediation plans that address regulatory gaps while maintaining business continuity.

Executive-level compliance leadership without a full-time hire. The vCCO works with the executive team on compliance strategy, regulatory readiness, audit preparation, risk assessment, governance structure, and internal audit oversight.

FDA and EU MDR inspections require clear documentation, controlled systems, and evidence of compliance. Felaris conducts mock audits, identifies compliance gaps, develops remediation plans with clear timelines, and prepares inspection response.

Computer system validation, data integrity under 21 CFR Part 11, and GAMP 5 validation extend directly to AI/ML systems in regulated environments. The compliance team and the AI team are working the same problem. See Fractional CAIO Services.

• Preparing for an FDA inspection or EU MDR notified body audit
• ERP, LIMS, or QMS implementation requiring IQ/OQ/PQ validation
• Acquisition of a company without validated systems or a compliant QMS
• Existing QMS with CAPA backlog or non-conformance findings
• Transitioning from FDA 21 CFR Part 820 to ISO 13485 alignment
• Building a compliance program from the ground up