This ISO 13485 training is a one-day course for the introduction to medical device manufacturers. There is no such word as negotiable within the vocabulary of the medical device world and that is the sole purpose of the development of this course.
Description
This ISO 13485 training is a one-day course for the introduction to medical device manufacturers. There is no such word as negotiable within the vocabulary of the medical device world and that is the sole purpose of the development of this course.
All regulatory requirements are more stringent throughout each step of the products life cycle not limited to the servicing and delivery. As its functions varies its main purpose is to help and support international, national trade and businesses by developing standards that are recognised and followed worldwide.
Who should attend:
If you fall in any of the below stated groups, you should consider getting on this course:
Instructor led Training (onsite at the company)
Virtual Training
In person (at our base)
Regulatory Affairs Managers
Internal and external Auditors
Consultants
Anyone involved with the implementation of the standard.
Key Course Topics:
Introduction to ISO 13483:2016
Standards relating to ISO 13483:2016
The use of ISO 13483:2016 as basis for a QMS for medical device
manufacturers
Understanding the relationship between ISO 13483 and European
Medical Device Directives
The use of ISO 13483:2016 as the basic of regulatory
requirements worldwide
Progression step:
Progression is a 'road map' for each individual, and each may progress at a different rate or take a different path to get to the next stage in their learning journey. This course is the next step leading towards becoming an Internal Auditor for ISO 13485 (2 Day course).
Assessment Details:
Course schedule:
Dates remain flexible please email or call one of our administrators to get available dates.
Remote E-Learning:
All our learning can be carried out remotely therefore you do not need to travel miles just to get to college. You can receive the same quality of learning via our weekly webinars and online videos. Ours tutors are available to interact with questions and able to assist you to learn. We advise students to have access to: Computer/Laptop, Printer/Scanner, and access to internet.
Delivery Methods:
Entry Requirements:
About Us
Our mission statement, ‘Where imagination takes flight, and dreams become a reality,' implies that our mission is to provide a platform where students can explore their passions, unlock their potential and soar to new heights.
We can dedicated to fostering a creative and supportive learning environment that encourages delegates to think outside of the box, embrace curiousity, venture on a new career path, continue to develop personal career knowledge, pursue their dreams and or be better equipped to continue to live the dream.
Through our innovative courses and personalized guidance, we aim to inspire and empower everyone who will show interest in our courses in order to turn their imagination into tangible results. Join us on this exciting journey where imagination takes flight and dreams become a reality.
We promise to hear your concerns, act on them accordingly, and allow your training journey to be as smooth as possible. We hope to grant an opportunity to as many persons as possible to secure a bigger and brighter future as we offer a wide range of different courses, which are all delivered by our highly qualified and experienced faculty, whose core purpose is to transform the lives of students, through working with them and their many partners to provide education, opportunities, and positive outcomes.
In this way, Spade Learning Academy aims to deliver high-quality yet affordable education, flexibility, and learning to the local community. It strives to achieve the highest level of excellence and performance for its students by running courses that are fit for the global employment market. As we plan work together grant you your desires, we hope you will meet our expectations and utilize every resource we provide.
Welcoming Message
A very warm welcome to Spade Learning Academy. We are exceptionally pleased that you have either considered us or chosen us to help you fulfil your educational and career aspirations. We are proud to offer a dynamic and multifarious approach to education & training, and we view you, the student, as partners in this approach.
The academy is staffed by well-qualified, caring professionals who will help you achieve your potential. If you can match this with hard work and a proactive approach to your studies, then we are sure your journey with us will be both enjoyable and fruitful.
The Vision
Spade Learning Academy’s vision is to stay a challenging, relevant leader in education, to continue to meet the higher skills needs of an increasingly global marketplace, and to stand by our word at all given times.
Mission Statement
Our key purpose is to transform the lives of our learners and meet their needs while partnering with the different departments as necessary to help and guide them all the way and provide opportunities and positive outcomes.
Admission Process
If you are considering gaining admission to Spade Learning Academy, then you must submit an application form with the chosen program. This document outlines in detail the application process and the steps involved in your admission to be admitted for study at the Spade Learning Academy. We have a dedicated admissions team who are on hand to provide advice and guidance if you are unsure about any aspect of the admissions process.
Step 1: Submit an application form
Once you have decided on the program you would like to study, you should first check that you meet all of the entry criteria (these can be found by visiting the webpage for your program); your application will be assessed against these criteria when deciding on your application. You should then complete the application form and submit it to Spade Learning Academy by one of the following methods:
On-line
Click on the ‘Admissions tab’ on the website homepage and then click on ‘Apply’ – this is usually the quickest way for us to receive your application. We advise all prospective students to complete the form online.
By Post
Click on the ‘Admissions tab’ on the website homepage. Then either click on ‘Apply Now' followed by the application form link or click on the ‘Application Form Download’. After downloading and completing the application form you must post it to:
Admissions Department
Before you apply, please make sure you read and follow the instructions carefully and that you complete all the relevant sections. There are no official closing dates except for workshops, but check the appropriate program page for the different entry points during the year.
Students are enrolled on a rolling basis; you can seek enrolment at any time, but we recommend that you submit your application form well before the intake you wish to join so there is time to process your application.
Step 2: Receive an offer
Once your application has been received by the admissions team, it will be assessed by one of our Admissions Officers. When reviewing your application, we will check that you meet the program entry criteria and English Language ability (This only applies to some of the courses we offer) – these are the criteria listed on the online program page.
We aim to provide a decision on your application within two working days from the date of receipt, provided the application form is complete. However, there may be certain circumstances in which we cannot respond within this time. If this is the case, we will update you on why there has been a delay in responding to your application and when you will likely be informed of the outcome.
If your application succeeds, the college will issue you a conditional offer letter (by e-mail). If your application is unsuccessful, the academy will send you an e-mail with an explanation of the outcome.
Step 3: Accept the offer
Before accepting your offer, please make sure you read the conditional offer letter carefully and that you can meet all of the conditions outlined. In particular, the conditional offer letter will contain important information about the program fee and when fees must be paid.
You need to respond to us (preferably by e-mail) letting us know that you would like to accept the offer along with any documents requested in the conditional offer letter.
Step 4: Enrol at the Academy
You must pay a minimum deposit towards your program fee before the Spade Learning Academy can enrol you in the course. The required amount can be found in the program fee document and will be clearly stated in your conditional offer letter. Accepted payment methods include a bank transfer, cash or cheque, and a payment link.
We will enrol you once we have received all the necessary documents and the payment has cleared. At the Spade Learning Academy, please visit the ‘Contact Us ’ tab on the website homepage if you want to ask further questions.
You will need to send us the following supporting documents:
Photocopy passport/ ID and proof of address
Photocopy educational certificates (as per your application form)
Your contact details – address where you are staying in the UK, contact phone number, and email address.
iv. At the time of enrolment, you must also sign an instalment plan – this is an agreement between you and Spade Learning Academy outlining how you will pay the remainder of your program fee.
Strategic Objectives
To offer courses, training, and placement that are widely demanded and beneficial in meeting potential students’ needs and fulfilling the community's skills shortage needs.
To promote fairness, equality, and diversity within the academy.
To ensure all academy support adds value to the student experience to optimise achievement.
To ensure the academy has an embedded culture of continuous quality improvement.
To ensure the academy is financially secure.
To ensure the academy demonstrates effective governance and management practices.
To provide proper and up-to-date information to all learners.
Academy Resources
All learning resources are provided online and can be supplied in hard copy. Textbooks provided digitally are current and up-to-date. Regarding practical lessons, learners can attend workshops to gain that experience. Pre-recorded lessons are available to maintain flexibility in learning.
Students
We are home to a vibrant international community of students from the UK and worldwide. We believe a truly global perspective is vital to their education and personal development, and we ensure they leave the academy fully prepared to excel in the international community.
Academic Staff
Our teaching staff and internal assessors are carefully selected based on qualifications and experience. Passionate about the subjects they teach, they are dedicated to supporting students and driving them to maximize their potential. Many of our academic staff have also worked in a variety of settings and can bring their professional experience and expertise to digital classrooms.
Our Facilities
Our digital community is always equipped with current and informative resources. These can be translated by yourself how you see fit, and it is expected to complete the course within their given times. In addition, the academy has a dedicated intranet allowing access to course materials and information such as policies, newsletters, and minutes of meetings. We have extended to create an online community and forum to help you throughout the learner’s journey.
The ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to ...
ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed
The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.
This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
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