Certificate in ISO 13485 for Regulatory Affairs

Name: Certificate in ISO 13485 for Regulatory Affairs
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The Certificate in ISO 13485 for Regulatory Affairs is a vital course for professionals seeking to excel in the medical device industry. This certification program focuses on the international standard for medical device quality management systems, ISO 13485.

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AboutThisCourse

It equips learners with essential skills to navigate the complex regulatory landscape, ensuring compliance and fostering continuous improvement. In an industry where meticulous adherence to regulations and quality standards is paramount, this course is in high demand. It empowers professionals to effectively develop, implement, and maintain compliant quality management systems. By doing so, it enhances career prospects and contributes to organizational success. Upon completion, learners will be proficient in interpreting and applying ISO 13485 requirements, conducting internal audits, and managing risk and performance metrics. This makes them highly valuable assets in the medical device sector, paving the way for career advancement and increased industry impact.

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CourseDetails

• Introduction to ISO 13485 & Regulatory Affairs
• Understanding Medical Device Regulations
• Quality Management System (QMS) Requirements
• Implementing ISO 13485: Key Components
• Risk Management in ISO 13485
• Documentation Control for ISO 13485
• Internal Audits and Management Review
• CAPA Management in ISO 13485
• Preparing for ISO 13485 Certification Audit

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EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

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NotRegulatedAuthorized
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FastTrack GBP £140

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AcceleratedLearningPath

ThreeFourHoursPerWeek
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StandardMode GBP £90

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FlexibleLearningPace

TwoThreeHoursPerWeek
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CERTIFICATE IN ISO 13485 FOR REGULATORY AFFAIRS

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London School of International Business (LSIB)

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05 May 2025

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