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NQA ISO 13485 (Medical Devices) Introduction and Implementation Training

2 Days Level 1 – Introduction

All of our courses are being held virtually by our expert tutors. Book online below to secure your place.

Gain insight into the application of ISO 13485:2016 as the basis for a Quality Management System used by medical device manufacturers.

**Please note that we encourage all our delegates sitting on virtual courses to have access to a webcam. This will enable you to interact with both the tutor and other course attendees.**

Available dates and venues

- +VAT per delegate

Course aims

The aim of this course is to provide delegates with knowledge of the requirements of the ISO 13485:2016 standard, discussing key principles and concepts as well as how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulations.

Delegates will gain the knowledge to be able to understand, develop, implement and maintain ISO 13485:2016 management system.

What will I learn?

  • How to understand and describe the purpose and intent of a quality management system in the context of medical devices.

  • How to summarise the contribution that ISO 13485:2016 can make towards the development of safe, effective and compliance medical devices.

  • How to state the structure, key points, aims and objectives of the ISO 13485 standard.

Is this course right for me?

This course is aimed at:

  • Anyone involved in the implementation / operation of the standard

  • Senior Management, Quality Managers, Regulatory / Compliance Managers

  • Auditors

  • Consultants

What else do I need to know? (Public courses only)

  • Dress code - Smart casual

  • Food & refreshments - You will be provided with lunch and refreshments throughout the day for the entire course. Please do let us know if you have any allergies or specific dietary requirements.

  • Proof of attendance - You will be sent a certificate of attendance following your training.

  • What to bring - You don't need to bring anything with you. You will be loaned a copy of the relevant standard(s) for reference and will be provided with writing materials and a copy of the presentation.

Why choose NQA training?

  • Expert trainers – All of our trainers have a wealth of experience and expertise in their field and are eager to pass this onto you in an effective way that you can take away and utilise.

  • Quality assured – Our trainers are assessed by delegates both annually and after each course. 99% of attendees scored overall trainer delivery, skills and knowledge as good or very good.

  • Interactive learning – We see the importance of practical and hands on learning so we have built this into all of our courses to further deepen your knowledge and engagement.

  • Small class sizes – Our courses all have a maximum of 12 delegates to ensure you are getting the best learning experience possible.

  • A learning journey – We offer a step-by-step training journey to help you improve over time. From introduction courses all the way up to our lead auditor training. We are always developing new training to keep up with the changing world of ISO standards.

To see the other courses we have running download our 2022 training calendar here.

Are you wondering which type of NQA training course is most suitable for you? Our Journey Guide will point you in the right direction.

 

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To discuss your training requirements call now on 0800 052 2424 or email us via our contact form choosing 'training' as your enquiry type.