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.
Introduction to the Medical Device Regulation (MDR)
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.
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.
Risk Implementation ISO 14971 2018
This course offers practical insight on applying ISO 14971, the knowledge required to apply a risk management process, and how it relates to the product life cycle.
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.
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.
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.