Certification Audits
The ISO 13485 Foundation Course is designed to provide a fundamental understanding of the ISO 13485 standard, which pertains to Quality Management Systems for medical device manufacturers and suppliers. It benefits a wide range of professionals from this course, including:
There are no formal prerequisites for this ISO 13485 Foundation Course.
ISO 13485 sets the standards for Quality Management Systems that are crucial for organisations supplying medical devices and related services. It ensures compliance with customer and regulatory requirements, making it an essential framework for the medical device industry. This ISO 13485 Foundation Course offers a comprehensive introduction to the vital topic of ISO 13485 and its relevance in the healthcare industry.
Understanding ISO 13485 is of paramount importance for professionals in various roles. Quality Managers, Regulatory Affairs Specialists, Auditors, Manufacturing Supervisors, and individuals involved in the designing, producing, or distributing of medical devices should aim to master ISO 13485. This knowledge empowers them to ensure product quality, safety, and compliance, leading to career advancement and opportunities in the industry.
The Knowledge Academy provides 1-day ISO 13485 Foundation Training that equips delegates with essential knowledge. It covers the requirements of medical devices, the phases of implementation, and the intricacies of conducting an ISO certification audit. Delegates will gain the skills to navigate the complex medical device quality management landscape.
Course Objectives
Upon completing this course, delegates will benefit from a deep understanding of ISO 13485, enhancing their competence in quality management and compliance within the medical device industry. This knowledge will open doors to career progression and a more substantial contribution to the sector's growth and safety.
ISO 13485 Foundation Exam Information
To achieve the ISO 13485 Foundation, candidates will need to sit for an examination. The exam format is as follows:
Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Foundation Course. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.
Live classes
Join a scheduled class with a live instructor and other delegates.
Interactive
Engage in activities, and communicate with your trainer and peers.
Global Pool of the Best Trainers
We handpick from a global pool of expert trainers for our Online Instructor-led courses.
Expertise
With 10+ years of quality, instructor-led training, we equip professionals with lasting skills for success.
Global Reach
With classes running in all timezones, access any of our courses and course material from anywhere, anytime.
Master ISO 13485 Foundation with a flexible yet structured approach that combines live, expert-led sessions and self-paced study. With weekly one-to-one tutor support and consistently high pass rates, you’ll receive tailored guidance and achieve real results.
Structured Yet Flexible Learning
Take part in scheduled, instructor-led sessions with real-time feedback, while enjoying the freedom to study independently. Interactive resources and progress tracking tools help you stay motivated and on target.
Engaging & Interactive Training
Join dynamic live sessions featuring discussions, practical activities, and peer collaboration. Learn from ISO 13485 Foundation industry experts and reinforce your knowledge with self-paced modules—plus, connect with professionals in your field.
Expert-Led Course
Gain valuable insight from experienced trainers during live sessions, and revisit course materials anytime to deepen your understanding. This method offers the ideal balance between expert guidance and independent learning.
Global Training Accessibility
Access top-quality training across time zones—anytime, anywhere. Whether at home or on the go, our expert-led sessions and flexible study materials support your goals, and help you on the journey towards the certification.
Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Foundation Course. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 13485 Foundation sessions.
Highly experienced trainers
Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience
State of the art training venues
We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible
Small class sizes
Our Classroom courses with limited class sizes foster discussions and provide a personalised, interactive learning environment
Great value for money
Achieve certification without breaking the bank. Find a lower price elsewhere? We'll match it to guarantee you the best value
Streamline large-scale training requirements with The Knowledge Academy’s In-house/Onsite ISO 13485 Foundation Course at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.
Tailored learning experience
Leverage benefits offered from a certification that fits your unique business or project needs
Maximise your training budget
Cut unnecessary costs and focus your entire budget on what really matters, the training.
Team building opportunity
Our ISO 13485 Foundation Course offers a unique chance for your team to bond and engage in discussions, enriching the learning experience beyond traditional classroom settings
Monitor employees progress
The course know-how will help you track and evaluate your employees' progression and performance with relative ease
To help and support our clients we are providing a limited number of 250 daily discount codes. Hurry, first come, first served!
If you miss out, enquire to get
yourself
on the waiting list for the next day!
Our training experts have compiled a range of course packages on a variety of categories in ISO 13485 Foundation, to boost your career. The packages consist of the best possible qualifications with ISO 13485 Foundation, and allows you to purchase multiple courses at a discounted rate.
ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) in the medical device industry. It ensures consistent design, development, production, and delivery of medical devices that meet regulatory requirements.
Iso 13485 Foundation Course enhances your understanding of ISO 13485 standards, improves your ability to implement and maintain a compliant QMS, and boosts your career prospects in the medical device industry.
There are no specific prerequisites for attending the course, but a basic understanding of quality management systems or the medical device industry can be helpful.
Iso 13485 Foundation Training is ideal for quality managers, regulatory professionals, medical device manufacturers, and individuals responsible for maintaining or auditing QMS in the medical device sector.
The course includes expert-led training sessions, comprehensive study materials, case studies, and practical exercises to provide a thorough understanding of ISO 13485 requirements and implementation.
Iso 13485 Foundation Training takes 1-day to complete during which delegates participate in intensive learning sessions that cover various course topics.
Yes, many ISO 13485 courses include an assessment to evaluate your understanding. Successful completion may lead to certification.
Yes, we provide 24/7 support to assist you with any queries and ensure a seamless learning experience throughout your training.
Yes, we offer self-paced online courses, allowing you to learn at your convenience with access to recorded sessions and interactive resources.
The course covers topics such as the scope of ISO 13485, QMS principles, regulatory requirements, documentation, risk management, and internal auditing techniques.
You will develop skills in implementing, auditing, and maintaining a compliant QMS, along with knowledge of regulatory standards and best practices in the medical device industry.
This training prepares you for roles such as Quality Assurance Manager, Regulatory Compliance Officer, Internal Auditor, and QMS Consultant in the medical device sector.
If you face access issues, you can contact our 24/7 support team, who will assist you promptly in resolving any technical or administrative concerns.
You will learn about the ISO 13485 standard, its principles, QMS implementation, regulatory compliance, and how to conduct effective audits to ensure quality in medical devices.
The Knowledge Academy in the United Kingdom stands out as a prestigious training provider known for its extensive course offerings, expert instructors, adaptable learning formats, and industry recognition. It's a dependable option for those seeking Iso 13485 Foundation Training.
The training fees for ISO 13485 Foundationin the United Kingdom starts from £1295
The Knowledge Academy is the Leading global training provider for ISO 13485 Foundation.
Please see our ISO 13485 Training courses available in the United Kingdom
Ahmed Mahmoud
Very good, thank you for the support
Kevin Auton
Excellent trainer. Knowledgeable, personable and a great motivator.
Adam Scott
Sandra was a pleasure and really helped visualize the process.
You won't find better value in the marketplace. If you do find a lower price, we will beat it.
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
close
Press esc to close
close
Fill out your contact details below and our training experts will be in touch.
If you wish to make any changes to your course, please
log a ticket and choose the category ‘booking change’
close
Thank you for your enquiry!
One of our training experts will be in touch shortly to go over your training requirements.
close
Press esc to close
Back to Course Information
Back to course information
Thank you for your enquiry!
One of our training experts will be in touch shortly to go overy your training requirements.
Thank you for your enquiry!
One of our training experts will be in touch shortly to go over your training requirements.
