Global Certificate in Medical Device Compliance Principles
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โข Global Regulatory Landscape: Understanding global regulations and agencies governing medical device compliance such as FDA, EU MDR, MDSAP, etc.
โข Quality Management System (QMS): Overview of QMS requirements, ISO 13485, and its role in medical device compliance.
โข Design Control and Risk Management: Implementing design controls and risk management processes in medical device development.
โข Clinical Evaluation and Post-Market Surveillance: Conducting clinical evaluations, establishing post-market surveillance, and understanding their impact on compliance.
โข Labeling and Instructions for Use (IFU): Complying with regulations for labeling, language requirements, and IFU creation.
โข Medical Device Reporting and Vigilance: Reporting adverse events, maintaining vigilance, and complying with Medical Device Reporting (MDR) requirements.
โข Supply Chain Management and Distribution: Ensuring compliance in supply chain management, distribution, and logistics.
โข Inspection and Audit Preparedness: Preparing for inspections and audits, understanding common findings, and implementing corrective actions.
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