Advanced Certificate in ISO 13485: Smarter Outcomes

Name: Advanced Certificate in ISO 13485: Smarter Outcomes
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The Advanced Certificate in ISO 13485 is a comprehensive course designed for professionals aiming to gain expertise in the quality management system for medical devices. This course highlights the importance of understanding and implementing ISO 13485:2016, fostering a culture of continuous improvement, and ensuring compliance with regulatory requirements.

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AboutThisCourse

In an industry where safety and quality are paramount, there is a growing demand for professionals with a deep understanding of ISO 13485. By earning this advanced certificate, learners will develop the skills to lead and manage medical device organizations, enhancing their career prospects and value in the job market. The course covers critical topics such as risk management, document control, and regulatory affairs, equipping learners with the tools to streamline processes, reduce costs, and improve overall performance. By pursuing this certificate course, professionals can demonstrate their commitment to excellence, making them a valuable asset in the medical device industry.

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CourseDetails

• ISO 13485 Overview
• Quality Management System (QMS) Principles
• ISO 13485 Requirements and Implementation
• Risk Management in ISO 13485
• Documentation Control in ISO 13485
• Internal Audits and Management Review
• Training and Competence in ISO 13485
• Measurement, Analysis, and Improvement in ISO 13485
• Preparing for ISO 13485 Certification Audit

CareerPath

The Advanced Certificate in ISO 13485: Smarter Outcomes is a valuable credential for professionals in the UK's medical device sector. This certificate is designed to enhance expertise in quality management, regulatory affairs, clinical research, and engineering roles. 1. Quality Manager: A Quality Manager ensures that medical devices meet the necessary standards and regulations. Averaging a 25% share of the market, these professionals earn between £35,000 and £55,000 annually. 2. Regulatory Affairs Specialist: With a 20% share, Regulatory Affairs Specialists manage compliance and registration of medical devices in the UK and abroad, earning £30,000 to £60,000 per year. 3. Clinical Research Associate: As clinical trials become increasingly vital, the demand for Clinical Research Associates grows. They account for 15% of the market, earning £25,000 to £50,000 annually. 4. Biomedical Engineer: Biomedical Engineers, with a 18% share, design and develop medical equipment, earning £25,000 to £60,000 per year. 5. Manufacturing Engineer: Manufacturing Engineers, with a 22% share, focus on the production and assembly processes of medical devices, earning £25,000 to £50,000 annually. This Advanced Certificate in ISO 13485 helps these professionals stay updated on industry needs, ensuring smarter outcomes for themselves and their employers.

EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
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FastTrack GBP £140

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ThreeFourHoursPerWeek
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StandardMode GBP £90

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TwoThreeHoursPerWeek
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ADVANCED CERTIFICATE IN ISO 13485: SMARTER OUTCOMES

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London School of International Business (LSIB)

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05 May 2025

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