INTRODUCTION TO QUALITY MANAGEMENT FOR MEDICAL DEVICES AND ISO 13485
ONLINE COURSE
Learn about quality management and the requirements of ISO 13485 during this self-paced, interactive online course.
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Course length
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10-15 hours
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Course fee
(per person)
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€ 299
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Course description
This online course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. It introduces tools and methods on how to work successfully and efficiently within a quality management system.
Topics covered on the course include: the regulatory framework, the quality management system (QMS), documentation pitfalls, risk-based approach, management responsibility, product realization & traceability.
It is relevant for people working with QA related tasks in a medical device organisation (including authoring, reviewing and approving procedures) and those who are typically engaged in supporting QA related tasks such as CAPA, complaints, risk management, documentation and internal auditing.
The online course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course.
Peter Sebelius (PMP) is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that has authored the latest versions of ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience too having developed, amongst other things, a mechanical chest compression and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
Benefits for you
Make quality management more tangible
Make quality management more tangibleWe have designed this course to be as pragmatic as possible in order to make quality management more tangible. There are real-life examples and quiz questions to test understanding throughout. You will learn what you need to do, why and how.
Understand the meaning of the requirements
Reading the ISO 13485 standard is easy (albeit not particularly entertaining), but understanding the meaning of the requirements and how to implement them in an effective way is much harder. This course gives you the keys to unlock the meaning of the requirements and the ways you need to work operationally to meet the requirements.
Self-paced learning
You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.
Course programme
- Welcome
- What you need to know
- Set your course completion date
- Pre-course assessment quiz
- What is quality management and why it is important
- The regulations and standard
- What is a quality management system?
- Shall or should
- The structure of the QMS
- Processes, policies and procedures
- Maintaining the QMS
- Which standard should you use?
- Getting to know the ISO 13485
- Risk management and ISO 13485
- ISO 13485 stakeholders
- Different types of audits
- ISO 13485 internal audit requirements
- Documents and records
- Establish and implement a new document
- Update and maintain a document
- Control of records
- Quality policy and objectives
- Management review
- Human resources
- Responsibility and authority
- Infrastructure and work environment
- Selling a medical device
- Design and development and projects
- Design and development planning
- Design and Development inputs
- Design and development outputs
- Verification and validation
- Design and development transfer
- Design and development review
- Product documentation
- Purchasing
- Production (part 1)
- Production (part 2)
- Process validation
- Measuring equipment and calibration
- Nonconforming products
- Design and development changes
- Feedback and data analysis
- CAPA
- Complaints
- Final exam
- Course evaluation
NOTE – The course program structure is subject to change
Frequently asked questions
We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form.
If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.
Testimonials
Group purchase
You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.
For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.
With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.