Global Certificate in Health Technology Regulatory Affairs & Compliance
-- ViewingNowThe Global Certificate in Health Technology Regulatory Affairs & Compliance is a comprehensive course designed to meet the growing demand for professionals with expertise in health technology regulation. This course emphasizes the importance of regulatory compliance in the health technology industry, covering topics such as regulatory strategy, clinical trials, market approval, and post-market surveillance.
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โข Regulatory Landscape and Compliance in Health Technology – Understanding global regulations, compliance requirements and standards for health technology products.
โข Health Technology Life Cycle – Navigating the regulatory pathway from product development to post-market surveillance.
โข Quality Management Systems – Implementing and maintaining a QMS according to ISO 13485 and other relevant standards.
โข Clinical Evaluation and Investigations – Designing and conducting clinical evaluations and investigations for health technology products.
โข Risk Management – Identifying and mitigating risks associated with health technology products through application of ISO 14971.
โข Labeling, Instructions for Use and Language Requirements – Ensuring compliant labeling and IFU for global markets.
โข Post-Market Surveillance and Vigilance – Managing post-market surveillance and vigilance activities in accordance with regulatory requirements.
โข Regulatory Inspections, Audits and Enforcement – Preparing for and managing regulatory inspections, audits and enforcement actions.
โข International Trade & Regulatory Affairs – Navigating international trade regulations, tariffs and customs for health technology products.
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