Global Certificate in Regulatory Affairs for IVD Compliance

Name: Global Certificate in Regulatory Affairs for IVD Compliance
Price: 149 GBP
Availability: InStock

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The Global Certificate in Regulatory Affairs for IVD Compliance is a comprehensive course that equips learners with critical skills in the regulatory affairs sector, particularly for in vitro diagnostic (IVD) devices. This certification is crucial in the rapidly evolving medical device industry, where regulatory compliance is paramount.

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AboutThisCourse

This course is designed to meet the growing industry demand for professionals who understand the complex regulatory landscape of IVD devices. Learners will gain expertise in global regulations, quality systems, and standards, enabling them to ensure compliance throughout the product lifecycle. By completing this course, learners will be able to demonstrate a deep understanding of regulatory affairs, enhancing their career prospects in this specialized field. They will be equipped with the skills to navigate the intricate regulatory landscape, reducing compliance risks and ensuring the safe and effective use of IVD devices.

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CourseDetails

• Global Regulatory Overview for IVDs: Understanding the global regulatory landscape for In Vitro Diagnostic (IVD) devices, including key agencies and regulations
• Regulatory Strategy for IVDs: Developing a regulatory strategy to ensure compliance with IVD regulations, including gap analysis and risk management
• Quality Management System (QMS) for IVDs: Implementing and maintaining a QMS for IVDs, including ISO 13485 and FDA QSR requirements
• IVD Design and Development: Designing and developing IVDs in compliance with regulations, including design controls and documentation requirements
• IVD Manufacturing and Process Validation: Manufacturing IVDs in compliance with regulations, including process validation and cleaning validation
• IVD Labeling and Packaging: Ensuring compliance of IVD labeling and packaging with regulations, including UDI and IFU requirements
• IVD Clinical Evaluation and Performance: Conducting clinical evaluations and ensuring the performance of IVDs, including Leach and Walker review
• IVD Post-Market Surveillance: Implementing and maintaining post-market surveillance for IVDs, including adverse event reporting and vigilance
• Regulatory Submissions for IVDs: Preparing and submitting regulatory applications for IVDs, including 510(k) and CE Marking submissions

CareerPath

The Global Certificate in Regulatory Affairs for IVD Compliance prepares professionals for various roles in the UK market. Among them, Regulatory Affairs Specialists take the lead with 45% of the market share, followed by IVD Compliance Officers (30%) and Regulatory Affairs Managers (20%). The remaining 5% is held by Clinical Affairs Professionals. This 3D pie chart offers a visually appealing way to understand the current job market trends, emphasizing the need for skilled professionals in this niche.

EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
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BasicComputerSkills
DedicationCompleteCourse

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FastTrack GBP £149

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AcceleratedLearningPath

ThreeFourHoursPerWeek
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StandardMode GBP £99

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TwoThreeHoursPerWeek
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GLOBAL CERTIFICATE IN REGULATORY AFFAIRS FOR IVD COMPLIANCE

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UK School of Management (UKSM)

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05 May 2025

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