Advanced Certificate in ISO 13485 for a Changing World

Name: Advanced Certificate in ISO 13485 for a Changing World
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The Advanced Certificate in ISO 13485 for a Changing World is a comprehensive course designed to equip learners with the essential skills needed to excel in the ever-evolving medical device industry. This certificate program focuses on the latest updates and revisions to ISO 13485, the international quality management system standard for medical devices, and emphasizes the critical role of risk management and change control in today's rapidly changing landscape.

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AboutThisCourse

With a strong emphasis on practical application, this course empowers learners to implement and maintain effective quality management systems, reduce risks, and ensure compliance with regulatory requirements. This program is ideal for quality professionals, engineers, and managers working in the medical device industry who are looking to advance their careers, stay ahead of industry trends, and drive success in their organizations. By completing this certificate course, learners will not only gain a deep understanding of the ISO 13485 standard but also develop the skills needed to lead and succeed in a rapidly changing world. Join this program and take the first step towards career advancement and success in the medical device industry.

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CourseDetails

• Introduction to ISO 13485:2016 & Changing Regulatory Landscape
• Understanding Medical Device Quality Management System (QMS)
• Risk Management in ISO 13485:2016
• Design and Development of Medical Devices
• Documentation and Record Keeping in ISO 13485:2016
• Implementing and Maintaining ISO 13485:2016 QMS
• Internal Audits and Management Review
• Preparing for ISO 13485:2016 Certification
• Continuous Improvement in a Changing World

CareerPath

In the ever-evolving world of medical devices, professionals with an Advanced Certificate in ISO 13485 are highly sought after. This advanced qualification equips individuals with the skills and knowledge to excel in roles such as Quality Manager, Regulatory Affairs Manager, ISO Consultant, Compliance Officer, Engineering Manager, and Senior Technician. Let's dive into the details of each role and explore the growing demand for these professionals in the UK. The **Quality Manager** is responsible for ensuring that all products and services meet or exceed customer expectations, while adhering to the organization's policies and procedures. With an Advanced Certificate in ISO 13485, professionals can expect a median salary of £40,000, and the job market is expected to grow by 8% in the next five years. A **Regulatory Affairs Manager** oversees the development and implementation of an organization's regulatory strategy to ensure compliance with relevant regulations and standards. This role typically offers a median salary of £45,000, with a 10% growth rate in job opportunities in the UK. An **ISO Consultant** helps organizations understand, implement, and maintain ISO 13485 standards, providing guidance and expertise to streamline processes and ensure compliance. The median salary for an ISO Consultant is around £42,000, and the demand for their skills is projected to increase by 12% in the coming years. A **Compliance Officer** is responsible for ensuring that all activities within an organization comply with relevant laws, regulations, and standards. Professionals with an Advanced Certificate in ISO 13485 can expect a median salary of £38,000, with a 7% growth rate in job opportunities. An **Engineering Manager** oversees the engineering department, developing and implementing strategies to improve products, processes, and efficiency. With an Advanced Certificate in ISO 13485, Engineering Managers can expect a median salary of £50,000 and a 6% growth rate in job opportunities. A **Senior Technician** supports engineers and other professionals in the design, development, and testing of medical devices. Professionals with an Advanced Certificate in ISO 13485

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 FOR A CHANGING WORLD

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London School of International Business (LSIB)

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05 May 2025

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