Develop and execute validation strategies for medical devices, including equipment, processes, and software. Involved in the validation planning process, including risk assessment and validation approach. Create and maintain validation documentation, such as protocols, reports, and change control documentation. Perform validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Collaborate with cross-functional teams, including R&D, Quality Assurance, and Regulatory Affairs, to ensure compliance with applicable regulations (e.g., FDA, ISO 13485). Conduct gap analyses and create remediation plans for any non-compliance issues. Stay current with industry trends and regulations to ensure best practices in validation processes.
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