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.
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.
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.