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ISO 13485 Certification Courses
The Knowledge Academy is Globally Recognised as the Market Leader in training Medical Device Quality Professionals. Our " Medical Devices Quality Expert Team" consist of 20 leading Medical Device Quality Management Professionals who on an average have more than 11 years of experience in the field of Medical Device Quality Management. Our dedicated instructors have developed a unique teaching style to help aspiring candidates successfully Manage Quality of the Medical Devices.
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ISO 13485 Training Courses Overview
ISO 13485 is an international standard for quality systems for medical device manufacturers across the globe. This course will cover Medical Devices Quality Management System (MDQMS) policy, processes, performance measures, management commitment, management review, internal audit, and continual improvement for the process followed for medical device quality control in the organisations. ISO 13485 course consists of 4 levels of transition that will help delegates to understand the features and functionality of ISO 13485. Our ISO 13485 courses cover the standard in detail, understanding of its clauses, and what you can do to improve manufacturing quality, reduce defects and create happier customers and client experience which help you to pass your exam in very 1st attempt.
We deliver training solutions to corporate, government agencies, public sectors, international organisations and private individuals. Our subject matter experts have plentiful industry knowledge, who know how to make their topics engaging to create a memorable and valuable learning environment. Our dedicated staff work persistently to provide in-house training to clients that wish to have the convenience and comfort of working within their familiar surroundings.
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ISO 13485 Training Courses
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About ISO/IEC 13485
ISO 13485 is a quality standard for the design and manufacture of medical devices. Our ISO 13485 courses cover the standard in detail, providing guidance on understanding its clauses and what you can do to your business to improve manufacturing quality, reduce defects and produce happier customers and clients.
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What Our Clients Say About Us
Sophie Davies
Quality Manager
I just completed my ISO 13485 foundation course and it was excellent. I learn about the key concepts of the ISO 13485 standard. The course provided in-depth content and it is according to the latest ISO 13845 guidelines. My course trainer Ava was really helpful and eased me into concepts by using innovative techniques. I found this course very useful for getting my ISO 13485 certification. Thank you, Ava and knowledge academy.
Phillip Brown
ISO Implementer
Just finished my ISO 13485 lead implementer course and I have to say that it has been an experience of a lifetime. This course of theknowledgeacademy is very detailed and provided me with all explanations of the requirements and examples for the fulfilment of the essential provisions of the international standard. My trainer was accommodating throughout the course and she explained everything uniquely so I can grasp every topic quickly.
Liam Jones
ISO 13485 Consultant
This ISO 13485 internal auditor course is designed with detailed information of all ISO 13485 standard clauses. It was very well executed and content of the course was detailed and matched my expectations. My instructor Jack was very well informed and handled my queries patiently. His examples of the topics were convenient and helped me immensely to grasp the topics.
Jacob Williams
Quality Assurance Supervisor
For me, this course efficiently covered all main themes and topics of the ISO 13485 standards. The content was delivered in the form of high-quality presentation. My doubts were handled efficiently by my trainer. This course helped me to get my ISO 13485 certification without any hassle. I would totally recommend this course to my peers.
Lucas Baker
Lead Auditor
This ISO 13485 lead auditor course has been a great help to me to comprehend the complex and critical clauses of the ISO 13485. Knowledge academy and my trainer both were very helpful during the training. My trainer’s in-depth explanation and unique style of teaching ISO 13485 standard helped me immensely to understand ‘em without any difficulty. Personally, I would recommend this course for companies who are keen to set up a quality management system for medical devices quickly as well as for individuals who want to grow professionally in this field.
David Hickland
Medical Devices Professional
I attended the ISO 13485 Foundation course and it was a good learning experience. My experienced trainer took an innovative approach toward the topics and got me through the course without any difficulty. I have no prior knowledge of this ISO 13485, but after attending this course, I got my certification in only my first try. I’m pleased and will recommend knowledge academy for this course.
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Hurry UpFrequently Asked Question
What is ISO 13485?
ISO 13485 is an internationally recognised standard used in Medical Devices Quality Management Systems (MDQMS) requirements for regulatory purposes for organisations involved in the medical device industry. Companies are using compliance to this standard to obtain the certification of their Quality Management System.
What is the main purpose of ISO 13485?
Safety and quality are not negotiable in the medical devices industry, that was the purpose behind the development of ISO 13485. Regulatory requirements are more stringent throughout every step of a product’s life cycle, including service and delivery. Organisations in the industry are expected to demonstrate their quality management processes and ensure best practice are followed throughout the manufacturing and delivery process.
What is ISO and what are its functions?
ISO is the International Organisation for Standardisation. Its function is to help and support international and national trade and businesses by developing standards that are recognised and followed everywhere.
How many levels are in there ISO 13485 course?
In this ISO 13485 course there are 4 levels which are Foundation (Level 1), Internal Auditor (Level 2), Lead Implementer (Level 3), and Lead Auditor (Level 4).
What will I learn from ISO 13485 Lead Auditor course?
In this ISO 13485 Lead Auditor course, you will learn all the necessary ISO 13485 standards to maintain the quality of medical devices. You will also learn the various responsibilities of Lead Auditor like planning, coordinating with team, reporting, and reviewing reports are few of them. This course also covers procuring records and auditing terminology for medical device quality.
What will I learn from ISO 13485 Foundation course?
In this ISO 13485 Foundation course, you will learn all the requirement of ISO 13485 for regulatory purposes. You will learn about implementing ISO 13485 in your organisation, documentation requirements, and making continues improvement to improve medical equipment quality.
Will this course help me to get a better job with a high salary package?
Professionals with knowledge of ISO 13485:2016 Medical Device Quality Management System will have higher ranks and job opportunities in manufacturers and vendors for ensuring the quality of medical equipment. You will have various job opportunities to work as a regulator, implementer, and auditor (internal or external).
Can Knowledge Academy deliver corporate or in-house training?
Yes, our special in-house delivery staff work incessantly to provide training to clients who wish to have the convenience and comfort of working within their familiar surroundings.
Can knowledge academy deliver the training to more than 1000 delegates of my company?
Yes, we already trained over 1000 delegates from multiple internationally renowned organisations. In such cases where the delegates are more in number, we are providing training in batches.
I am unable to find the course I am looking for.
The knowledge Academy provides training on over 3000 different subjects. Please contact us if you are unable to find your ideal course in the above course list.
What delivery method I can choose for the ISO 13485 training courses?
You can choose below delivery method according to your requirement:
- Online: If you want to learn at your own pace and at any time in the day or night.
- Online Instructor-led/virtual: If you want to learn virtually from an instructor in the comfort of your home.
- Classroom: If you want to attend training in The Knowledge Academy venue.
- Onsite/Corporate: If you are looking for a training solution for your employees or company.