Executive Development in Healthcare Device Compliance
-- ViewingNowThe Executive Development in Healthcare Device Compliance certificate course is a crucial program designed to meet the growing industry demand for professionals with a thorough understanding of regulatory requirements and quality standards in healthcare device manufacturing. This course emphasizes the importance of compliance in ensuring patient safety, product efficacy, and business success.
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⢠Regulatory Affairs in Healthcare Devices: Understanding global regulations and compliance requirements for healthcare devices.
⢠Quality Management Systems (QMS): Implementing and maintaining a QMS in accordance with international standards such as ISO 13485.
⢠Design Control and Risk Management: Applying design control processes and risk management principles to healthcare device development.
⢠Clinical Evaluation and Trials: Conducting clinical evaluations and trials to demonstrate the safety and efficacy of healthcare devices.
⢠Labeling, Instructions for Use (IFU), and Packaging: Designing and implementing compliant labeling, IFU, and packaging for healthcare devices.
⢠Post-Market Surveillance (PMS) and Vigilance: Implementing PMS and vigilance systems to monitor and report adverse events related to healthcare devices.
⢠Supply Chain Management and Distribution: Managing supply chain and distribution activities to ensure compliance with regulatory requirements.
⢠Audits and Inspections: Preparing for and managing audits and inspections by regulatory authorities.
⢠Regulatory Intelligence and Strategy: Monitoring regulatory changes and developing strategies to maintain compliance and gain market access.
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