Introduction to the Medical Device Regulation (MDR).
This course will help you uncover and understand the key regulatory changes introduced, as well as the impact they may have on your organisation.
ISO 13485 Auditor/Lead Auditor - IRCA & CQI Certified.
Continue your development by attending this CQI & IRCA accredited course. Over five days, learn how to audit Quality Management Systems against ISO 13485 requirements.
ISO 14971 Risk Implementation.
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.
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.
Introduction to the new IVDR.
This course outlines the structure and scope of the IVDR, the changes introduced and the hot topics under the new regulation.
Introduction to ISO 13485:2016.
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).
Implementation of the IVDR.
Learn how to apply the IVDR requirements, create technical documentation develop a robust and proactive post market surveillance system and start developing a transition.
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 Auditor/Lead Auditor.
This course details the role & responsibilities of an Auditor/Lead Auditor, including processes & planning, gathering objective 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.