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The following topics will be taught during this course
Module 1: Introduction to ISO 13485:2016
Module 2: ISO 13485 Clauses 1 and 2
Module 3: ISO 13485 Clauses 3 and 4
Module 4: Requirements and Quality Systems
Module 5: Overview of ISO 13485:2016 Requirements
Module 6: Implementation Phases of the ISO 13485 Frameworks
Module 7: Conducting an ISO 13485 Certification Audit
Module 8: Relationship Between ISO 13485 and ISO 9001
This course is intended for:
There are no formal prerequisites for attending this ISO 13485 Foundation Training course.
ISO 13485 establishes quality management system requirements for organisations that must consistently demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements. Regulatory requirements apply to all organisations, regardless of size or kind, except as clearly defined. These requirements also apply to linked services provided by an organisation where the criteria relate to medical equipment. This training session equips learners with the requirements of medical devices, implementation phases, and conducting an ISO certification audit. Obtaining the necessary quality management skills through this ISO training will help individuals advance in their careers and get higher job profiles.
In this 1-day ISO 13485 Foundation Training course, delegates will thoroughly understand quality management systems and how to manage medical devices. During this training, delegates will learn about documentation requirements that define the content of medical device files and a description of the project. They will also learn about the gap analysis checklist to assess running procedures and their compliance with ISO 13485. This course will be led by our highly skilled and professional trainer with years of experience teaching ISO courses.
After completing this training, delegates will be able to design and develop medical devices and activities associated with them. They will also be able to promote awareness of regulations company-wide and review the management to identify improvements and regulatory requirements.
This training course includes:
ISO 13485 Foundation Exam
In order to complete this ISO 13485 Foundation training course, delegates will need to pass the associated examination. The exam is:
Why choose us
Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.
Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.
This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.
All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning experience.
We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible
We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience
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This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.
Our courses can be adapted to meet your individual project or business requirements regardless of scope.
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This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.
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Flexible delivery methods are available depending on your learning style.
Resources are included for a comprehensive learning experience.
"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"
Joshua Davies, Thames Water