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 organization. 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.
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 organization.
Maximize your learning and your time when you take advantage of an additional day of insight through ISO 13485:2016 Appreciation and Interpretation part of this select course package. This course package combines...ISO 13485:2016 Appreciation and Interpretation (Day 1) & ISO 13485:2016 Internal Auditor (Day 2 & 3) - An Appreciation courses provides you with the foundational information to understand quality management systems and how process effectiveness directly links with business performance and in an Internal Audit course, you’ll learn how to audit processes for effectiveness and efficiency.
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
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.
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.
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.
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.
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.
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 organization.