Training

Public Training: IVDR Fundamentals an how to work with a NoBo (London)

March 05, 2020

Date: April, tbc

Location: London

Language: English

Costs: Regular € 875.- (including lunch & drinks)

Package option:  5 sessions € 3900.-

Qserve has designed a 5-session training program to assist in determining the crucial steps needed for your organization. These training sessions will provide the opportunity to interact, network and discuss your organizations ‘challenges.There are two options to participate in the program: through the open enrollment sessions in London/ Frankfurt or follow the Virtual sessions (US time).
We offer flexible options for your company, team, or individual experts. You can send different experts from your company to the sessions and still qualify for the package and you can choose from the dates and locations (London, Frankfurt or Virtual).  

 

Introduction:

There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more recourses to maintain as well as implement. 

Learning objectives: 

  • Background to the IVDR, what drove the changes and how this impacts implementation

  • Definitions, placing on the market, in-house exemption (LDT), distance sales and how these impact your IVDR submissions

  • Classification and conformity routes

  • How to select a Notified Body (NoBo)

  • How to work with NoBo's effectively

More detailed information about the training will follow soon.
Sue Spencer
Post date: December 11, 2019
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