Global Certificate in ISO 13485: Risk Management

Name: Global Certificate in ISO 13485: Risk Management
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The Global Certificate in ISO 13485: Risk Management is a crucial course for professionals seeking to excel in the medical device industry. This certificate program focuses on risk management strategies that align with ISO 13485, an internationally recognized standard for quality management systems in medical device manufacturing.

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AboutThisCourse

With the increasing demand for safe and effective medical devices, there is a growing need for professionals who possess a deep understanding of ISO 13485 and risk management principles. This course equips learners with the essential skills to identify, assess, and mitigate risks in medical device design, development, and manufacturing. By completing this course, learners will not only gain a competitive edge in the job market but also demonstrate their commitment to quality and patient safety. Career advancement opportunities in regulatory affairs, quality assurance, and operations are just a few of the benefits of this certificate course. In summary, the Global Certificate in ISO 13485: Risk Management is an investment in your career that will provide you with the skills and knowledge necessary to succeed in the medical device industry.

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CourseDetails

• Introduction to ISO 13485 & Risk Management: Understanding the importance of risk management in medical devices and how ISO 13485 supports it.
• Risk Management Process: Identifying and assessing risks, implementing risk controls, and monitoring the effectiveness of risk management activities.
• Risk Management Tools: Utilizing tools such as FMEA, Hazard Analysis, and Risk Matrix to support risk management activities.
• Risk Management in Design and Development: Integrating risk management into the design and development process to ensure that risks are identified and managed early.
• Risk Management in Production, Installation, and Servicing: Ensuring that risks are managed throughout the production, installation, and servicing stages of the medical device lifecycle.
• Risk Management in Purchasing: Managing risks associated with the selection and use of suppliers and purchased materials.
• Risk Management in Transportation and Storage: Identifying and managing risks associated with transportation and storage of medical devices.
• Risk Management in Product Realization and Release: Ensuring that risks are managed throughout the product realization process, from design and development to final release.
• Risk Management in Post-Market Surveillance: Utilizing post-market surveillance data to identify and manage risks associated with medical devices in the market.
• Continual Improvement of Risk Management: Implementing a plan for continual improvement of risk management activities, including periodic reviews and updates to the risk management process.

CareerPath

The ISO 13485 Risk Management certification is a valuable asset for professionals in the UK medical device industry. This 3D pie chart highlights the distribution of popular roles and their market trends associated with this certification. *Quality Managers* hold the largest percentage of demand, driving focus on ensuring high standards and compliance within organisations. *Regulatory Affairs Managers* follow closely behind, emphasising the importance of navigating complex regulatory landscapes for medical devices. *Compliance Engineers* and *ISO 13485 Consultants* are also sought-after, contributing to the development, implementation, and maintenance of risk management systems. Lastly, *Internal Auditors* play a crucial role in monitoring and improving these systems, securing 5% of the market share. This data-driven representation showcases the value and versatility of the Global Certificate in ISO 13485: Risk Management, aligning with industry relevance and trends in the UK.

EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

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NotAccreditedRecognized
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FastTrack GBP £140

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ThreeFourHoursPerWeek
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StandardMode GBP £90

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FlexibleLearningPace

TwoThreeHoursPerWeek
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GLOBAL CERTIFICATE IN ISO 13485: RISK MANAGEMENT

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London School of International Business (LSIB)

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05 May 2025

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