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In Vitro Diagnostic Regulations (IVDR)

Opleiding

The In Vitro Diagnostic Medical Devices Regulations (IVDR) define common regulatory requirements dealing specifically with the safety, quality and performance of in vitro diagnostic medical devices (IVDs), thereby bringing them into line with other medical devices. The Regulations are intended to ensure that IVDs do not compromise the health and safety of patients, users and third parties and attain the performance levels attributed to them by their manufacturer.

In vitro diagnostic devices become more and more important in daily medical routine to make care more efficient. These medical devices are subject to regulatory requirements.

The training is set up to give first the basic background info on the Medical Device Regulations, i.e. how to bring a medical device to market, and on the specific category of in vitro medical diagnostic devices.  Specific attention is focused on the methodology to perform the ‘clinical evaluation’ of IVD-medical devices via determination of the sensitivity and specificity of the diagnostic test. Additional ISO-standards are considered in relation to the IVD-medical devices regulations. Following elements are addressed:

  • Medical devices intended for self-testing (e.g. for blood glucose or pregnancy testing)
  • Sampling procedures for acceptance testing – statistical methods
  • Performance evaluation of IVD-medical devices
  • Metrological traceability of calibrators

Praktisch

15/11/2017 9u - 17u Leuven
08/12/2017 9u - 17u Hasselt
Schrijf in

Prijs

LEDEN € 550
NIET-LEDEN € 633

KMO-portefeuille: vraag hier uw subsidie aan en bespaar tot 40% op uw inschrijvingsprijs.

Erkenningsnummer Allanta: DV.O105117

Word lid

Uw opleiding in detail

Agendapunten

The training outlines the essentials of the Regulations

  • The MDR and IVDR
  • Explanation of terms and definitions
  • Essential requirements
  • Relation to risk management
  • Conformity assessment procedures: regulatory pathways to market
  • Clinical evaluation : what ?

In addition, essential elements of applicable IVDD-related ISO standards are addressed:

  • Clinical evaluation: how ?
  • classification of IVD-medical devices – focus on self testing devices
  • sampling procedures and performance testing
  • the clinical laboratory environment for IVD-device testing
  • traceability and validation of quality control tests
  • stability of reagents
  • labeling requirements

Uw
certificaat

All students who attend 75% of classes, will receive a certificate of participation.


Uw
docent

Carine Vandervorst is een ervaren lead auditor in de sector van medische hulpmiddelen, in vitro diagnostica, farmacie, sterilisatietechnieken, cosmetica en logistiek.

Ze heeft bovendien beroepservaring in apotheken, ziekenhuisapotheken en klinische laboratoria én in het onderwijs op hogeschool- en universitair niveau. 

Carine bouwde met succes een ISO 17025 - kwaliteitssysteem uit in laboratoria, ondersteunde rusthuizen bij de invoering van HACCP en trad op als hoofdauditor en technisch auditor voor BELAC, het Belgische accreditatieorganisme.

De unieke combinatie van praktijkervaring aan weerszijden van het certificatie- en accreditatiespectrum zorgt voor een professionele 360 graden aanpak bij de begeleiding van organisaties.


Uw Contact-
persoon

Nele Gregoor

TEL +32 (0) 11 870 944

info@allanta.be





deelnemer
Materialise
Materialise


Medical Materialise</br> </br> </br>

Hands-on, focus on detail, lots of extra input was given when asked for! Thank you!!  There were numerous posibilities to have discussions on certain topi...

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Sandra
Stam
Regus Surgical


Medical Regus Surgical</br></br></br>

Er werd een breed en gevarieerd programma aangeboden. Het publiek was divers, maar er waren zeker en vast interessante topics of cases voor elk individu.

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Laurel
Berzanskis
Materialise


Medical Materialise</br> </br> </br>

  I really liked the practical tips for doing an internal audit. Often, people overlook the value of learning the soft skills.

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Daniel
Sanchez
GSK


Medical GSK</br> </br> </br>

"The training was very well organized, the facilities and environment were quite good. I especially liked the format of 6 modules x 3 days, it allows an...

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