Executive Development in Healthcare Device Compliance

Name: Executive Development in Healthcare Device Compliance
Price: 149 GBP
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The 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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Über diesen Kurs

By enrolling in this course, learners will gain essential skills necessary for career advancement in the field. They will explore key topics such as FDA regulations, EU medical device directives, ISO 13485 quality management systems, and risk management. Upon completion, learners will be equipped to lead compliance initiatives, manage regulatory affairs, and drive quality improvement efforts in their organizations. In an era of increasing regulatory scrutiny and technological innovation, this course is a valuable investment in professional growth and development.

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Kursdetails

• 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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