ISO 13485:2016 Appreciation and Interpretation
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).
ISO 13485:2016 Auditor/Lead Auditor – CQI & IRCA Certified
This IRCA registered four day course details the role & responsibilities of an Auditor/Lead Auditor, processes & planning, gathering evidence and evaluation of findings.
Introduction to the InVitro Diagnostic MDR EU 2017/746
This course outlines the structure and scope of the IVDR, its rules, safety and performance requirements for CE marking and determining the conformity route.
Implementation of the In Vitro Diagnostic Device Regulation (IVDR)
Learn about the IVDR's structure & scope, classification & conformity routes, safety & performance requirements, and developing a post-market surveillance system.
Implementation of the Medical Device Regulation (MDR)
Learn about the MDR's structure & scope, classification & conformity routes, safety & performance requirements, and developing a post-market surveillance system.
Medical Device Single Audit Program Implementation
This two day course enables medical device manufacturers to be audited only once for compliance with the standard and regulatory requirements of multiple authorities.
Preparing for Transition to ISO 13485:2016
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.
ISO 13485:2016 Implementation
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.
ISO 13485:2016 Internal Auditor
This two day course helps you improve your Quality Management System and understand best practice to conduct effective internal audits in accordance with ISO 13485:2016.
ISO 13485:2016 Update Workshop
This course covers the changes introduced in ISO 13485:2016 and how it differs to ISO 13485:2003 so that you can adapt your Quality Management System.