LIFERAFT LLC

QA/RA & Product Development Support: Expert support when you need it. From design controls and risk management to CAPA and supplier quality, we provide on-demand expertise to strengthen your product development and quality systems, without the need for full-time staff. QMS Audits and Gap Assessments: Prepare for regulatory audits with confidence. We conduct internal audits, mock inspections, and gap assessments to help you meet 21 CFR 820 (QSR/QMSR), ISO 13485, and EU MDR requirements - reducing risk, avoiding findings, and strengthening your QMS. Coaching & Training: Engaging, hands-on guidance in best practices. We provide expert training in design controls, risk management, supplier management, verification & validation, CAPA and root cause analysis… along with other key quality and compliance areas to help your team stay audit-ready and efficient.

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