FDA/MDR Compliance and System Validation

When regulatory compliance is slowing product development or blocking system upgrades, you need validation frameworks that satisfy auditors without creating bottlenecks. Felaris Global provides compliance advisory and Virtual Chief Compliance Officer services for medical device companies navigating FDA 21 CFR Part 11, ISO 13485, ISO 27001, and EU MDR requirements. We build compliant technology environments and quality systems that support business growth, not hinder it.

Enterprise systems in regulated environments require validation that satisfies FDA and regulatory requirements without delaying business initiatives. We develop risk-based CSV strategies and validation protocols for ERP, QMS, LIMS, and cloud-based business systems.

What you get: Risk-based CSV strategy development, validation master plans, system categorization and GAMP 5 classification, validation protocols (IQ/OQ/PQ), traceability matrix development, validation execution oversight

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.

What you get: QMS requirements definition, eQMS platform selection and implementation, process workflow design, documentation control systems, CAPA and risk management module configuration, audit trail and electronic signature compliance

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.

What you get: Compliance gap assessment, remediation roadmaps, audit preparation and readiness reviews, inspection support, post-market surveillance system design, technical file and DHF documentation frameworks

When you need senior compliance leadership but don't require a full-time executive, our vCCO services provide strategic compliance oversight and regulatory program management. We step into the compliance leadership role to build programs, manage audits, and guide regulatory strategy.

What you get: Compliance program design and oversight, regulatory risk assessment and mitigation, policy and procedure development, internal audit program management, regulatory authority liaison, cross-functional compliance governance, inspection and audit readiness

Third-party systems and suppliers in regulated environments require qualification and ongoing oversight. We establish vendor validation programs and supplier quality management processes that meet regulatory requirements.

What you get: Supplier qualification frameworks, vendor audit programs, supplier quality agreements, change control for vendor-managed systems, periodic review protocols

FDA Regulations: 21 CFR Part 11 (Electronic Records and Signatures), 21 CFR Part 820 (Quality System Regulation)

ISO Standards: ISO 13485 (Medical Devices QMS), ISO 27001 (Information Security), ISO 9001 (Quality Management)

EU Regulations: Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746)

Compliance Frameworks: GAMP 5, ICH Q9 (Quality Risk Management)