In Vitro Diagnostics Regulation

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TRAINING

In Vitro Diagnostics Regulation

The new EU-IVDR brings about many changes, including many definitions, new conformity assessment routes, new Notified Body designations and more. On top of that, there is a completely revised rule-based classification system and stricter requirements for safety and on analytical and clinical performance. Much more details have been included in the general safety and performance requirements replacing the current essential principles of the Directive, and above all: no grandfathering.

 

 

 

 

IN VITRO DIAGNOSTICS

All In Vitro Diagnostics trainings

IVDR Fundamentals

The new structure and revised scope of the IVD, the classification rules, technical documentation changes and Post Market surveillance, you will learn during this course.

 

IVDR Transition 

This training focusses on practical guidance to implement IVDR from determining the gaps from your current documentation and processes and the IVDR requirements.

 

How to write a technical file

This training focusses on practical guidance to fulfil the technical documentation requirements in the EU-IVDR.

 

Fundamentals and how to work with a NoBo

How to select and work with NoBo's effectively

Technical Documentation

More information will follow soon

Risk Management

More information will follow soon

IVDR PMS/PMPF

Learn the PMS and PMPF requirements, how to prepare plans and repost and implementation for existing devices

Preparing QMS for IVDR

What will change? What to expect in unannounced audits? Internal audits and IVDR readiness

PRRC

The MDR and IVDR require that manufacturers and Authorized representatives have a person responsible for regulatory compliance. Qserve organizes training for persons that will be appointed by manufacturers or Authorized Representatives as PRRC.

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