Training

Virtual Training: IVDR Fundamentals an how to work with a NoBo

March 26, 2020

Date: 26th of March 2020

Location: Virtual

Language: English

Costs: 1 virtual training € 700.- / $ 790.-  

Package option: 5 Virtual Training courses - € 2500.- / $ 2825.-

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. 

Training concept:

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. It is also possible to attend only one training by choice.

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).  

Note: In the Virtual program you will have a web-based training per subject and then there is an optional in-house workshop to discuss your own documents.

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.

Costs

Pricing for the London/Frankfurt Training Courses:

  • 1 Day training - € 875.-
  • 2 Days training (Technical Documentation) - € 1750.-
  • 5 Training courses pass including workshops - € 3900.- 

Pricing for the Virtual Training Courses:

  • 1 Virtual Training - € 700.- / $ 790.-
  • 5 Virtual Training courses - € 2500.- / $ 2825.-
  • Tailored workshop: price on application

If you would like to apply for the 5 (virtual) training courses, please contact us.

Sue Spencer
Post date: December 12, 2019
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