Regulatory Strategy and Submission Support
We direct regulatory strategies tailored to your product risk profile and target markets. Our team manages the end to end submission process for the U.S. FDA, EU MDR/IVDR, and other global regions, ensuring technical documentation is robust and submissions are coordinated seamlessly across all stakeholders.
Quality Management System Excellence
We architect and maintain quality management systems aligned with ISO 13485, FDA Quality Management System Regulation (QMSR), and Medical Device Single Audit Program (MDSAP). From process optimization to audit readiness, we build scalable frameworks that ensure compliance while supporting your operational efficiency and long term growth.
Product Realization and Digital Compliance
We govern design controls, risk management, and requirements traceability to align with your R&D milestones, ensuring that validation and verification tests support your submissions. Our oversight ensures a robust design transfer process, and the establishment of a precise Device Master Record (DMR) for compliant manufacturing. Additionally, we provide technical leadership for Computerized Systems Validation (CSV), ensuring full alignment with 21 CFR Part 11 and GAMP 5 principles.
Operations and Manufacturing Quality
We oversee the transition to full-scale production, including the direction of process validation activities (IQ/OQ/PQ), labeling and UDI controls, and distribution and service quality. We integrate your supply chain into your quality system through strategic supplier qualification, quality agreements, and targeted audits.
Auditing, Remediation, and Post-Market Surveillance
We direct rigorous internal, supplier, and mock certification audits to identify and close compliance gaps. Our team governs the entire post-launch phase, managing remediation plans, CAPA, and post-market surveillance systems. We provide executive representation for communications with regulatory authorities to ensure continued product safety and compliance.
Strategic Capability Building and Leadership
We provide specialized executive leadership coaching to develop quality and regulatory leaders, equipping them with strategies to foster a strong compliance culture. For organizations in transition, we also provide interim Q&R executive leadership to maintain stability and continuity.