Medical Device Training Courses

LRQA offer a range of medical device training courses to support your organisation, including MDR, IVDR and ISO 13485:2016.

All of our courses are available as public courses that you can book online, or as in-house, customisable courses that can be delivered at your own premises at a date and time that suits you.

MDR Courses

Introduction to the Medical Device Regulation (MDR)

As a forward-looking manufacturer operating in the highly regulated and high stakes world of medical devices manufacturing, you want to understand the new regulation and its impact on your organisation. This training course will help you uncover all the key regulatory changes that you need to know. Like all other LRQA training courses, this will be delivered by trained and qualified tutors with deep sector-specific technical expertise.

Medical Device Regulation (MDR) Implementation

A two day course providing details of the new MDR which replaces the existing MDD (Medical Device Directive 93/42/EEC) and AIMDD (Active Implantable Medical Device Directive 90/385/EEC). This course is primarily intended for enterprises who already manufacture products against the existing MDD. It can be delivered as either a public or in-company event but is seen as particularly attractive as in-company where the content can be tailored to suit the needs of the organisation.

IVDR Courses

Introduction to the new IVDR

As a forward-looking manufacturer operating in the highly regulated and high stakes world of medical devices manufacturing, you want to understand the new regulation and its impact on your organisation.

IVDR Implementation

A two-day course providing details of the new IVDR which replaces the existing IVDD (In Vitro Device Directive 98/79/EEC). This course is intended for enterprises who already manufacture products against the existing IVDD or whose products are now affected by the introduction of the new IVDR.

ISO 13485:2016 Courses

ISO 13485:2016 Update Workshop

This course will inform you of the principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, in order to recognise to what extent your Quality Management System requires adapting.

Preparing for ISO 13485:2016

This comprehensive, one-day course is designed for those who are responsible for managing the transition of their management system and who want to learn about the latest requirements of the ISO 13485:2016 standard.

ISO 13485:2016 Appreciation and Interpretation

This one day, introductory course provides an overview of ISO 13485:2016, and promises to give delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS).

ISO 13485:2016 Implementation

This two-day ISO 13485:2016 Implementation course is for those who want to design and implement an effective QMS based on ISO 13485:2016, for companies who are preparing for ISO 13485 certification or those that are looking to improve the effectiveness of your current management system.

ISO 13485:2016 Internal Auditor

This two-day ISO 13485:2016 Internal Auditor training course is for those that want to add value to their organisation, improve the effectiveness of the QMS and understand the best practices to conduct an effective internal QMS audit in accordance with the requirements of ISO 13485:2016.

ISO 13485:2016 Auditor/Lead Auditor

This four day course is designed to give you a detailed understanding of the role and responsibilities of an Auditor or Lead Auditor, covering topics including audit processes and planning, gathering objective evidence and evaluation of audit findings.