Implementation of the Medical Device Regulation (MDR)
Course Type
- Public
- In-house
Course Type
- Public
- In-house
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
Course Type
- Public
- In-house
Course Type
- Public
- In-house
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
Course Type
- Public
- In-house
Course Type
- Public
- In-house
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 Internal Auditor
Course Type
- Public
- In-house
Course Type
- Public
- In-house
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 – CQI & IRCA Certified
Best seller
Course Type
- Public
- In-house
Course Type
- Public
- In-house
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 Medical Device Regulation (MDR)
Course Type
- Public
- In-house
Course Type
- Public
- In-house
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.