Training

Virtual Training: What you need to know before you start IVDR implementation - IVDR Fundamentals

July 06, 2020

Date: 6th of July 2020

Time: 16:00h - 18:00h CEST  / 10am - 12pm EDT

Location: Virtual

Language: English

Cost: special price € 395 instead of € 495.-


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 6-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.

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.

Learning objectives: 

  • Responsibilities of the manufacturer, distributer and authorised representatives including testing services, distance sales and the in-house exemption (LDT) What is the impact on IVDR submissions?
  • Classification and conformity routes interpreting the rules
  • Factors influencing how you structure your technical files
  • Getting started
  • How Notified Bodies review and thing to consider before writing your technical files

Pricing for the Virtual Training Courses:

  • 1 Virtual Training - € 495.- / $590.-
  • 6 Virtual Training courses - € 2500.- / $ 2950.-
  • Tailored workshop: price on application

If you would like to apply for the 6 (virtual) training courses, please contact us.

Sue Spencer
Christie Hughes
Lorry Weaver
Post date: May 11, 2020
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