Masterclass Certificate in ISO 13485 Implementation

Name: Masterclass Certificate in ISO 13485 Implementation
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The Masterclass Certificate in ISO 13485 Implementation is a comprehensive course that equips learners with the essential skills needed to excel in the medical device industry. This certification course focuses on the implementation of ISO 13485, the international standard for quality management systems specific to the medical device industry.

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AboutThisCourse

By earning this certification, learners demonstrate their expertise in understanding and implementing quality management systems that meet regulatory requirements and ensure the safety and efficacy of medical devices. The demand for professionals with a deep understanding of ISO 13485 is high, as medical device companies must comply with these standards to operate in the global market. By completing this course, learners will be able to lead and manage ISO 13485 implementation projects, ensuring their organization's compliance with the standard and driving business success. This certification course is an excellent investment in one's career, providing learners with a valuable credential and the skills needed to succeed in a rapidly growing industry.

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CourseDetails

• Introduction to ISO 13485
• Understanding Medical Device Quality Management Systems
• Benefits and Requirements of ISO 13485 Certification
• Key Principles of ISO 13485:2016 and Changes from Previous Versions
• Risk Management in ISO 13485 Implementation
• Documentation Control and Management in ISO 13485
• Implementing a Quality Policy and Quality Objectives
• Training and Competence in ISO 13485
• Internal Audits and Management Review for ISO 13485 Compliance
• Preparing for and Managing ISO 13485 Certification Audit

CareerPath

The medical device industry is growing, and with it comes the demand for professionals with expertise in ISO 13485 implementation. In the United Kingdom, various roles are in high demand, with competitive salary ranges and opportunities for career advancement. Below, we discuss the job market trends for professionals with a Masterclass Certificate in ISO 13485 Implementation in the UK. ## Quality Engineer Quality Engineers play a critical role in ensuring the safety and efficacy of medical devices, adhering to regulatory standards such as ISO 13485. They are responsible for designing and implementing quality assurance systems, conducting audits, and resolving non-conformities. As a Quality Engineer in the UK, you can expect a salary range between £30,000 and £50,000, depending on your experience and the organization. ## Regulatory Affairs Manager Regulatory Affairs Managers are responsible for ensuring that medical devices comply with regulatory requirements, both nationally and internationally. They manage the registration process, liaise with regulatory authorities, and develop regulatory strategies. In the UK, a Regulatory Affairs Manager can earn between £40,000 and £70,000 annually. ## Biomedical Engineer Biomedical Engineers design, develop, and test medical devices, integrating engineering principles with medical and biological sciences. They may also work on improving existing medical equipment or developing new technologies. Biomedical Engineers in the UK typically earn between £25,000 and £45,000 per year. ## Clinical Research Associate Clinical Research Associates are responsible for managing and coordinating clinical trials, ensuring that they comply with regulatory standards. They collect and analyze data, report findings, and collaborate with clinical teams. In the UK, Clinical Research Associates can earn between £25,000 and £50,000, depending on their experience and the organization. In conclusion, the medical device industry offers various career paths for professionals with a Masterclass Certificate in ISO 13485 Implementation. The UK job market is ripe with opportunities, and with the right qualifications, you can secure a well-paying position in this growing field.

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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MASTERCLASS CERTIFICATE IN ISO 13485 IMPLEMENTATION

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London School of International Business (LSIB)

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05 May 2025

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