Executive Development: MedTech Regulations
-- ViewingNowThe Executive Development: MedTech Regulations certificate course is a comprehensive program designed to provide learners with a deep understanding of the regulatory frameworks governing the medical technology industry. This course is crucial in a time when MedTech regulations are becoming more complex and stringent.
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⢠MedTech Regulations Overview: Understanding the regulatory landscape for medical devices and technology, including key players and global policies.
⢠Regulatory Affairs Management: Best practices for managing regulatory affairs in MedTech organizations, including regulatory intelligence, strategic planning, and compliance.
⢠Quality Management Systems (QMS): Implementing and maintaining QMS in MedTech organizations, with a focus on ISO 13485 and FDA Quality System Regulation.
⢠Clinical Evaluation and Trials: Conducting clinical evaluations and trials for MedTech products, including clinical investigation plans, study design, and data management.
⢠Medical Device Labeling and Packaging: Designing and implementing labeling and packaging systems that meet regulatory requirements and ensure patient safety.
⢠MedTech Post-Market Surveillance: Strategies for post-market surveillance, including vigilance, complaint handling, and corrective actions.
⢠Regulatory Submissions and Approvals: Preparing and submitting regulatory applications for medical devices, including 510(k) premarket notifications, premarket approvals, and European CE marking.
⢠MedTech Standards and Guidelines: Understanding and applying relevant MedTech standards and guidelines, including FDA guidance documents and international consensus standards.
⢠Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits, including responses to regulatory observations and citations.
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