Executive Development Programme in Building a World-Class Medical Device Regulatory Program
-- ViewingNowThe Executive Development Programme in Building a World-Class Medical Device Regulatory Program is a certificate course designed to empower professionals with the necessary skills to navigate the complex medical device regulatory landscape. This program is crucial for learners looking to stay updated with the ever-evolving regulations and standards in the medical device industry, ensuring compliance and mitigating risks.
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โข Regulatory Foundations for Medical Devices: Understanding regulations, guidelines, and standards for medical devices, including FDA, EU MDR, and ISO 13485.
โข Quality Management Systems (QMS): Designing, implementing, and maintaining a robust QMS for medical device regulatory compliance.
โข Regulatory Strategy and Planning: Developing a comprehensive regulatory strategy, considering market entry, product lifecycle, and global harmonization.
โข Clinical Evaluation and Investigational Plans: Designing, conducting, and reporting clinical evaluations, investigations, and post-market clinical follow-up studies.
โข Design Control and Risk Management: Implementing design controls and risk management processes throughout the product lifecycle, using ISO 14971 and FMEA.
โข Labeling, Instructions for Use (IFU), and Advertising: Ensuring accurate, compliant, and effective labeling, IFU, and promotional materials.
โข Regulatory Submissions and Approvals: Preparing, submitting, and negotiating regulatory submissions for medical devices, including 510(k), PMA, and technical files.
โข Post-Market Surveillance and Vigilance: Establishing and maintaining post-market surveillance and vigilance systems, including reporting adverse events and implementing corrective actions.
โข Regulatory Compliance Audits and Inspections: Conducting internal and external audits, managing inspection processes, and responding to Form 483s and Warning Letters.
โข Regulatory Intelligence and Training: Monitoring emerging regulatory trends, participating in industry forums, and developing training programs for regulatory professionals.
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