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 13485:2016 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.
ISO 14971:2018 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.
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.
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.
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).