Ali Chousein

Senior Systems & QA/RA Engineer supporting medical device companies in achieving audit readiness, strengthening Quality Management Systems, executing safety risk management and design controls, ensuring end-to-end traceability, and navigating regulatory requirements.

I typically support:

• Audit readiness and inspection preparation

• Implementation and improvement of Quality Management Systems aligned with ISO 13485

• Safety risk management activities in accordance with ISO 14971

• Design controls and traceability across the development lifecycle

• Regulatory compliance under FDA requirements and the EU MDR

• SaMD and medical software development in line with IEC 62304

With a background in software engineering, I bring a systems-level perspective to medical device development — bridging engineering and compliance—particularly in environments where software plays a critical role.

I have supported:

• FDA 510(k) clearance submissions

• DEKRA audits with zero major non-conformities

• Quality Management Systems implementation and remediation

• Execution of design controls across the development lifecycle

• Safety risk management activities

• Establishing traceability and compliance throughout development

I work with both established companies, scale-ups/start-ups, particularly where structured quality and regulatory frameworks are critical for growth, scaling, and market access.