Medical devices training courses.

This one-day course helps those who are responsible for managing the transition of their management system learn about the latest requirements of ISO 13485:2016.

This 2-day training covers the MDR, replacing MDD (Medical Device Directive 93/42/EEC) and AIMDD (Active Implantable Medical Device Directive 90/385/EEC).

Our 2-day training covers IVDR structure, classification and conformity, safety and performance reqs, and developing a post-market surveillance system.

Our 2-day course will help you learn best practices for conducting an effective internal audit in accordance with the requirements of ISO 13485:2016.

This IRCA registered four day course details the role & responsibilities of an Auditor/Lead Auditor, processes & planning, gathering evidence and evaluation of findings.

This course introduces ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS).

Learn how to design and implement an effective QMS based on ISO 13485:2016, prepare for certification or improve the effectiveness of your existing management system.

This course outlines the structure and revised scope of the MDR, the safety and performance requirements for CE marking and determining the appropriate conformity route.

This course outlines the structure and scope of the IVDR, its rules, safety and performance requirements for CE marking and determining the conformity route.