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 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.
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.
Medical Device Single Audit Program Implementation.
This two day course is for medical device manufacturers who want to be audited once for compliance with the standard and requirements of multiple regulatory authorities.
Preparing for 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.
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.
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.
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).