Masterclass Certificate in Medical Device Regulatory Compliance Essentials
-- ViewingNowThe Masterclass Certificate in Medical Device Regulatory Compliance Essentials is a comprehensive course that equips learners with critical skills necessary for success in the medical device industry. This program emphasizes the importance of regulatory compliance, an area of increasing significance due to evolving global regulations and heightened enforcement.
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โข Regulatory Foundations: Understanding the global regulatory landscape and frameworks for medical devices
โข Quality Management Systems: Designing, implementing, and maintaining QMS in accordance with ISO 13485
โข Medical Device Classification: Identifying device classes and their associated regulatory requirements
โข Labeling and Packaging: Ensuring compliant labeling and packaging for medical devices
โข Clinical Evaluation and Trials: Conducting clinical evaluations and trials to demonstrate safety and efficacy
โข Risk Management: Applying ISO 14971 to identify, assess, and mitigate risks in medical devices
โข Post-Market Surveillance: Implementing PMSS to monitor device performance and adverse events
โข Regulatory Submissions: Preparing and submitting technical files and design dossiers to regulatory authorities
โข International Regulations: Complying with regulations in key markets, such as FDA, EU MDR, and MDSAP
โข Compliance Audits and Inspections: Preparing for and managing regulatory audits and inspections
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