Certificate in Device Industry Best Practices
-- ViewingNowThe Certificate in Device Industry Best Practices course is a comprehensive program designed to equip learners with essential skills for success in the medical device industry. This course emphasizes the importance of industry-specific best practices, ensuring that learners are well-prepared to excel in this highly-regulated and rapidly-evolving field.
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โข Device Industry Regulations: An overview of the legal and regulatory landscape governing the device industry, including FDA regulations and international standards.
โข Design Controls: Best practices for device design, including design inputs, outputs, and verification and validation activities.
โข Risk Management: An introduction to risk management principles and processes, including risk identification, assessment, and mitigation strategies.
โข Quality Management Systems: A review of quality management systems and their role in ensuring device safety and efficacy, including ISO 13485 standards.
โข Document Control: Best practices for document control, including creation, review, approval, and distribution.
โข Change Management: A review of change management principles and processes, including impact analysis, approval, and implementation.
โข Supplier Management: Best practices for managing suppliers, including selection, evaluation, and monitoring.
โข Complaint Handling: An introduction to complaint handling, including reporting, investigation, and follow-up requirements.
โข Clinical Evaluation: Best practices for conducting clinical evaluations, including study design, execution, and reporting.
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