FDA Quality Remediation & Optimization
What We Do:
- Lead quality system gap analysis and remediation strategy
- Develop and lead FDA remediation plans
- Lead FDA communication responses and ongoing updates
- Develop complaint handling and investigations controls
- CAPA (Corrective and Preventive Action) management and remediation
- Quality system development
- Harmonize 21 CFR Part 820 with ISO13485:2016 into existing quality system
- Rebuild and improve CAPA framework
How We Do It:
FocusPoint Partners leads end-to-end Quality Management System transformation—from FDA remediation through sustainable operational excellence. We rapidly assess gaps, define a risk-based remediation strategy, and drive disciplined execution across CAPA, complaint handling, audits, and regulatory communications. Our team strengthens and harmonizes quality systems to meet 21 CFR Part 820 and ISO 13485:2016 expectations while simplifying processes to improve clarity, accountability, and performance. Where appropriate, we embed Agentic AI within compliant frameworks to enhance insight, oversight, and speed—resulting in a modernized, inspection-ready quality system built for long-term control and growth