Medical Devices Training Courses

For medical device quality management, regulatory affairs or internal audit professionals who want to stay up-to-date on the latest updates to key medical device standards and directives, and who wish to get a thorough and accurate understanding on how the changes impact their organisations.

LRQA provides a range of medical devices training courses which cater to different groups of quality management personnel, and these can be delivered either in-house or as public courses.

Unlike other Notified Bodies, LRQA’s trainers are practicing assessors who have access to deep technical insight and context as a result of their involvement in the technical committees and associations revising the medical directives and associated harmonised standards, such as European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA). This enhances your regulatory intelligence and helps you understand the latest regulatory developments in order to support your organisation’s long-term business objectives. Choose from a wide range of formats, including in-house, public, online, seminar, workshop styles, and bespoke training solutions tailored to your specific needs.

Our trainers are practicing assessors

All our trainers are practicing assessors, each with a wealth of experience conducting in-depth technical reviews of management systems throughout their careers. They understand your challenges, and are therefore well-positioned to take you through the changes and how they impact your organisation. Our trainers also use their assessment experience to understand your challenges, ensuring relevant course material. 

Ensure a seamless transition

LRQA’s range of bespoke and packaged training services support organisations worldwide with their transition to ISO 13485:2016 and MDSAP. 

Our transition training can be tailored to meet your requirements, allowing you to select the right training to ensure your seamless transition to the new standard. As well as training, LRQA can provide Gap Analysis, Preliminary and Transitional Assessment services to review, plan and help your organisation’s seamless transition.

LRQA is part of the Lloyd’s Register Group and at our heart sits a charity, the LR Foundation. Most organisations do something to make money but at Lloyd’s Register, we make money to do something. As a percentage of our profits go towards the LR Foundation, every time you choose LRQA, not only are you getting best-in-class professional assurance services, but you are helping to make a difference to our world.

Medical Devices Management Systems | List of Training Courses

ISO 13485:2016 Appreciation and Interpretation

Learn the differences between ISO 13485:2003, EN ISO 13485:2012 and ISO 13485:2016, as well as the essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements

ISO 13485:2016 Implementation

Learn how to design and implement an effective quality management system (QMS) based on ISO 13485:2016. Recommended if you are preparing for ISO 13485 certification, or if you want to improve the effectiveness of your existing QMS.

ISO 13485:2016 Internal Auditor

Understand the best practices to conduct an effective internal quality management system (QMS) audit in accordance with the requirements of ISO 13485:2016 and ISO 19011:2011, and how to add value to your organization and improve the effectiveness of the QMS.

ISO 13485:2016 Lead Auditor (IRCA)

You need this course if you want to audit Quality Management Systems against ISO 13485 requirements and you are an Auditor or Quality System Manager working in the medical devices sector and want to add to your credibility with a widely accepted qualification.

ISO 13485:2016 Update Workshop

Learn the principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, in order to recognize to what extent your Quality Management System requires adapting, as well as the differences between ISO 13485:2003 / EN ISO 13485:2012 and ISO 13485:2016.

Preparing for ISO 13485:2016

You will learn the structure of ISO 13485:2016 and how it interrelates with the Plan Do Check Act cycle. The differences between EN ISO 13485:2012 and ISO 13485:2016, and how the principal changes defined in the new standard may be accommodated by an organization that already has ISO 13485 certification and the transition timelines that apply.