- Easy to access online course
- Learn at your own pace, on a date and time to suit you
- Support from a dedicated e-learning team
Medical Devices
MD-QMS ISO 13485:2016 Foundation Course (Medical Device - QMS)
★★★★★ 4.5/5
A short, interactive course that is perfect for anyone who needs an understanding of ISO 13485. Delegates will learn the fundamentals of a Medical Devices Quality Management System and the MD-QMS ISO 13485:2016 Standard requirements.
This virtual course is ideal for anyone who prefers the convenience of ISO 13485 foundation training online; alternatively, if you have a team of 4-10 people, we can visit your workplace and offer in-house training on a date that suits you.
1 day course – 08:45-17:30
CQI and IRCA training level – Foundation
CQI and IRCA ref – FD132
(ATP No. 2427)
Online Training
Public Training
- For bookings of 1-3 people
- Choose from a timetable of scheduled course dates throughout the year
- Attend the course via a live virtual classroom.
From 445 pp + VAT
In-House Training
- For a team of 4-10 people
- Dedicated training on a date, time and location to suit you
- We can come to any workplace in the UK or overseas, or we can teach via a live virtual classroom
From 225 pp + VAT
First training provider in the WORLD to offer this Medical Devices course with CQI IRCA certification
We are proud to have a 100% pass rate for this course (data source CQI IRCA)
‘Book now pay later’ when booking onto a public training course in a virtual classroom (t&cs apply)
Who should attend this MD-QMS ISO 13485 Foundation Course?
- New auditors who wish to have an understanding of a medical devices quality management system against MD-QMS ISO 13485:2016.
- Anyone who participates in planning or managing an MD-QMS ISO 13485:2016 medical devices quality management system
- Delegates who plan to book onto an ISO 13485:2016 Internal Auditor or ISO 13485:2016 Lead Auditor course but don’t have sufficient knowledge of the Standard.
- People who are implementing an MD-QMS ISO 13485 MD QMS
- Existing auditors who need refresher training on MD-QMS ISO 13485:2016 or who need to update to the MD edition.
This course contributes to the development of personnel wishing to join the CQI or those wishing to register as an Auditor with the IRCA (International Register of Certified Auditors)
What will delegates learn on this MD-QMS ISO 13485 Foundation Course?
During this CQI and IRCA-certified medical devices QMS training course, delegates will learn the following knowledge –
- Quality management systems, principles and terminology, as applied to Medical Devices
- Interpreting the structure and requirements of MD-QMS ISO 13485:2016
- The Process Approach
- Core business processes for Medical Device manufacturing
- Regulatory compliance
- Medical device risk management
ISO 13485 requires personnel to be competent – this course provides knowledge to enable personnel to have an understanding of The Standard while performing their job role.
What you need to know
-
What is the format of the course?
- Combining engaging activities and tutor-led sessions, the course is 25% theory and 75% practical.
-
What is the course assessment?
- During the ISO 13485 foundation training, participants will be assessed on their general engagement with the course and involvement in the interactive activities.
- Delegates are required to have 100% course attendance (in accordance with CQI and IRCA rules)
-
What type of certificate will I receive?
- After attending this ISO 13485 Foundation medical devices training course, a CQI IRCA certificate will be awarded.
-
What's included in the course fee?
- Pre-course work to help prepare for training (Training Toolkit)
- Delegate training manual
- Post-course notes
- CQI and IRCA certificate
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£50 off when booking ISO 13485 Foundation course + ISO 13485 Internal Auditor or Lead Auditor course
FREE Training Toolkit
Our classroom and virtual courses come with a unique toolkit which helps you prepare for training, including:
Pre-course exercises
Series of training videos
Training manual
Book your course
- Easy to access online course
- Learn at your own pace, on a date and time to suit you
- Support from a dedicated e-learning team
We can travel to any workplace worldwide and teach your team on a date to suit you. Alternatively, we also offer online team training which is ideal for larger organisations with employees at several locations. Simply send us your requirements to receive a quote.
- OFFER
ISO 13485 Foundation + Internal Auditor = £50 off
- OFFER
ISO 13485 Foundation + Lead Auditor = £50 off
Find out when new dates are added, register your interest today.
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Learning styles for this course
Classroom Training
Traditional, face-to-face training delivered by an expert tutor in a physical classroom setting. Learn at one of our 6 UK training venues, or we can teach your team at your workplace.
Virtual Training
Access the course online via Zoom and interact with the tutor and other delegates in real time. Perfect for anyone who wants to learn from home or work without the need to travel.
In-House Training
Dedicated ISO training is available just for your team on a date and time to suit you. Suitable for a group of 4-12 auditors, we can travel to any workplace worldwide.
CQI and IRCA Certified Course
We are proud to be an Approved Training Provider for CQI and IRCA; the only organisation in the world that can award quality professionals with a Chartered status, making its brand one of the most trusted.Â
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When choosing a CQI IRCA-certified course, delegates can feel confident that the training will meet the requirements of an internationally recognised set framework.
Some of our happy customers
The course was very detailed and covered in great depth by the tutor, he always had the time and knowledge to answer any questions put forward and he kept the whole group engaged throughout the day. Top marks!!
Sam Limmack Orthoplastics ISO 13485 FoundationThe tutors enthusiasm to lead a course is second to none. His energy ensured I was engaged throughout.
Drew Evans Pelican Healthcare ISO 13485 FoundationWe all enjoyed the training provided. The tutor was engaging and interesting. He was also very knowledgeable on our processes so that was very helpful.
Bryony Hartley Serrations Ltd ISO 13485 FoundationThe training was very effective and met all of our delegates needs. All the delegates felt like they understood the content of the course and left with a solid understanding of ISO 13485
Scarlett Martindale Orthoplastics ISO 13485 FoundationI felt the online pre-course work was very useful before attending the course. It gave me a basic understanding of the subject (which I had none) and this greatly helped with the discussions on the training.
Robert H ISO 13485 FoundationThe course was good and gave me a better understanding of the Standard
Martin Evans Pelican Healthcare ISO 13485 FoundationIt's a difficult subject to keep interesting for a full day but the provider did well.
Anon ISO 13485 FoundationI found the course very helpful and the instructor had a wealth of knowledge and kept it interesting.
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Whatever your need, our experienced and knowledgeable Batalas team can guide you on the right training path to help you reach your professional goals.
ISO 13485 Foundation Training for your team
Do you have a group of employees who require ISO 13485 Foundation Training? One of our expert tutors can visit your workplace and teach your team on a date to suit you, or we can even deliver the course virtually if you prefer.
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