Masterclass Certificate in ISO 13485: Results-Oriented Approach

Name: Masterclass Certificate in ISO 13485: Results-Oriented Approach
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The Masterclass Certificate in ISO 13485: Results-Oriented Approach is a comprehensive course designed to empower professionals with the necessary skills to excel in the medical device industry. This certification focuses on ISO 13485, an international standard for quality management systems specific to the medical device industry, ensuring consistency, safety, and effectiveness in medical devices.

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AboutThisCourse

In today's competitive job market, this course is essential for career advancement, as it demonstrates a commitment to professional development and staying updated with the latest industry practices. By completing this course, learners will gain a solid understanding of the standard's requirements, how to implement and maintain a quality management system, and how to lead their organization to achieve certification. This masterclass equips learners with essential skills, knowledge, and tools to drive results and make a meaningful impact in their professional lives.

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CourseDetails

• Introduction to ISO 13485: Understanding the Standard & Its Importance
• Key Principles of Quality Management Systems in ISO 13485
• Implementing Risk Management in Medical Device Manufacturing
• Design and Development Controls for ISO 13485 Compliance
• Purchasing & Supplier Management in ISO 13485:2016
• Production & Service Controls for Medical Device Manufacturing
• Monitoring & Measurement of Product Realization in ISO 13485
• Internal Auditing & Management Review for Continuous Improvement
• Preparing for ISO 13485 Certification: Mock Audits & Documentation Review
• Maintaining & Improving ISO 13485 Certification: Case Studies & Best Practices

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EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

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ComplementaryFormalQualifications

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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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MASTERCLASS CERTIFICATE IN ISO 13485: RESULTS-ORIENTED APPROACH

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London School of International Business (LSIB)

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05 May 2025

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