Global Certificate in Healthcare Device Regulatory Compliance Basics
-- ViewingNowThe Global Certificate in Healthcare Device Regulatory Compliance Basics is a vital course for professionals involved in the healthcare device industry. This certificate program focuses on essential regulatory compliance knowledge, ensuring learners understand the complex regulatory landscape and how to navigate it effectively.
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โข Regulatory Fundamentals: Understanding global regulations, laws, and guidance related to healthcare device compliance.
โข Quality System Essentials: Establishing and maintaining a quality system to meet regulatory requirements.
โข Design Control and Risk Management: Implementing design controls and managing risks in healthcare device development.
โข Clinical Data and Evaluation: Gathering, analyzing, and reporting clinical data to support device claims and safety.
โข Labeling and Packaging: Designing and producing compliant labeling and packaging for healthcare devices.
โข Post-Market Surveillance: Monitoring and reporting adverse events, corrective actions, and product improvements.
โข Regulatory Submissions: Preparing and submitting technical files, design dossiers, and marketing applications.
โข Inspection Readiness: Preparing for and managing regulatory inspections and audits.
โข Enforcement and Penalties: Understanding enforcement actions, penalties, and recall processes.
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