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Program

March 18, 2021

General Status IVDR
  • 14h-15h: How realistic is the current Date of Application?
  • 15h-16h: Classification
  • 16h-16h30: Break*
  • 16h30-17h30: Conformity Assessment Procedures

March 22, 2021

Technical Documentation
  • 14h-15h: Building Technical Documentation. How to do it right the first time around?
  • 15h-16h: Technical Documentation of legacy devices
  • 16h-16h30: Break*
  • 16h30-17h30: Device labeling and UDI

March 25, 2021

From Intended Purpose to Clinical Evidence
  • 14h-15h: Intended purpose and the Performance Evaluation Plan
  • 15h-16h: Scientific Validity and Analytical Performance
  • 16h-16h30: Break*
  •  16h30-17h30: Clinical Performance and the Performance Evaluation Report

March 29, 2021

Quality Management System
  • 14h-15h: PMS, PMPF, PSUR, SSP – What are they and how do they work together?
  • 15h-16h: Impact of the IVD Regulation on key processes
  • 16h-16h30: Break*
  • 16h30-17h30: Risk Management

* During the breaks, you can schedule one-to-one meetings with the Qarad experts. Please send an email and specify which topic you want to discuss in more detail or what is your question and we will assign you to the correct expert.  

 

Practical 

The basic price is set at €1500 for all sessions or €500 per individual session.

However, Qarad also offers discount packages! If you want to subscribe multiple employees of the same company, check out our company ticket! For €5000, an unlimited amount of colleagues can join all sessions!

 

Price

Company ticket: €5000
  • Unlimited number of participants
  • Access to all 4 sessions
Individual ticket: €1500 
  • 1 participant
  • Access to all 4 sessions
Individual ticket: €500 
  • 1 participant
  • Access to either of 4 sessions

All prices are VAT exclusive.

 

Subscribe now

To subscribe to either all or a single Qarad webinar, click on the link below to complete the registration form.

Note that submitting the subscription form will automatically forward you to our online payment tool. You can immediately pay the subscription fee via credit card and you will receive the formal invoice afterwards. 

 Subscribe now

Trainers

Dirk Stynen, Ph.D.

Founder - President
Principal consultant

Maurizio Suppo, Ph.D.

Co-owner - Vice-President
Principal Consultant

Annelies Rotthier, Ph.D.

Device Compliance Manager
Senior Consultant 

Kirsten Van Garsse, M.Sc. 

Regulatory Affairs Manager
Director Authorized Representative Operations
Senior Consultant

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