CQT Solutions - Med Device regulations for Engineers

  • 03 Oct - 03 Oct 2019
  • Royal Marine Hotel
  • Dublin / Ireland

One day course that covers medical device regulations in Europe and the US.

Learn about the new medical device regulations in europe and their impact. 

Course was developed by regulatory experts in the medical device sector.  

This training is focused on the following key areas:

  • European Medical Device Directives (MDD)
  • New European Medical Device Regulations (MDR)
  • The role of the Notified Body
  • FDA regulatory requirements
  • Medical device classification
  • Marketing submissions
  • Post approval requirements

The attendee will gain an understanding of the following elements of the European medical device regulations:

  • The current medical device directives
    • Medical device directive (MDD)
    • In vitro medical device directive (IVDD)
    • Active Implantable Medical Device Directive (AIMD)
  • CE marking and the conformity assessment routes
  • Technical documents required for each product risk classification
  • Harmonized standards and their use in demonstrating assumption of conformity to the regulations
  • The new medical device regulations (MDR)
  • Control of Post market changes, and to understand the types of changes and corresponding regulatory submissions
  • Submission requirements for notified bodies when making changes, such as product transfers.

The attendee will gain an understanding of the following elements of the US regulations applicable to medical devices

  • The approaches to market in the US
    • 510(k)
    • PMA
  • Post Market changes, submission verses notification
  • The use of harmonized standards and FDA guidance documents
  • Minimum submission requirements for 510(k) and PMA

Manufacturing and Design Engineers involved in new product introduction and those that want to understand what is required when making changes to existing products and processes

Engineers will have the required knowledge in place to understand the basic regulatory requirements with respect to medical device.  They will gain an appreciation of the routes to market for medical devices and understand what is required when changes are made post market. This knowledge will be invaluable in development of product strategies and when liaising with regulators and regulatory affairs.