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The trainings offered in this academy focus on the standards, regulations and regulatory pathways related to clinical studies with medical devices.

TRAINING OFFERS

ISO20916:2019

(Planned)

In this e-learning you will get valuable, state-of-the-art information on the interpretation and implementation of the Good Study Practice in your clinical performance studies with IVD medical devices.

ISO14155:2020

In this e-learning you will get valuable, state-of-the-art information on the interpretation and implementation of the Good Clinical Practice in your clinical investigations with medical devices.

Regulatory pathways NL

(Planned)

In this e-learning you will get valuable, step-by-step practical guidance on the applicable regulatory pathways and application strategies of clinical studies with (IVD) medical devices in The Netherlands.

A selection of organizations that preceded you:

The ISO14155:2020, the Good Clinical Practice for

Medical Device Clinical Investigations

In this e-learning you will get valuable, state-of-the-art information on the interpretation and implementation of the Good Clinical Practice in your clinical investigations with medical devices.

You learn how to:

• add credibility to your clinical data

• protect your subject’s rights & safety 

• worldwide acceptance of your data

• no more findings during inspections

• avoid unnecessary risk for patients

• avoid unnecessary regulatory delay

• implement the regulation

• including practical solutions

Upon completion of this training, you will be able to correctly and successfully:

• Comprehend and apply the requirements of the ISO 14155 as a GCP guidance specifically for medical device clinical investigations from start to finish

• Understand how risk management is applied to all aspects of medical device clinical investigations

• Comprehend the different types of clinical investigation study designs and how ISO 14155’s requirements apply

• Adapt your procedures to the new requirements compared to the ISO14155:2011 version

The ISO20916:2019, the Good Study Practice for

In Vitro Diagnostic Medical Device Clinical performance studies

In this e-learning you will get valuable, state-of-the-art information on the interpretation and implementation of the Good Study Practice in your clinical performance studies with IVD medical devices.

You learn how to:

• add credibility to your clinical data

• protect your subject’s rights & safety 

• worldwide acceptance of your data

• no more findings during inspections

• avoid unnecessary risk for patients

• avoid unnecessary regulatory delay

• implement the regulation

• including practical solutions

Upon completion of this training, you will be able to correctly and successfully:

• Comprehend and apply the requirements of the ISO 20916 as a GSP guidance specifically for IVD medical device clinical performance studies from start to finish

• Understand how risk management is applied to all aspects of IVD medical device clinical performance studies

• Comprehend the different types of clinical performance study designs and how ISO 20916’s requirements apply

Regulatory Pathways in The Netherlands, for

(In Vitro Diagnostic) Medical Device Clinical Studies

In this e-learning you will get valuable, step-by-step practical guidance on the applicable regulatory pathways and application strategies of clinical studies with (IVD) medical devices in The Netherlands.

You learn how to:

• choose the right regulatory pathway

• understand which parties are involved

• identify which documents are needed for the application

• practical solutions for a smooth regulatory process

• plan for fast Ethics Committee and Competent Authority approval

• avoid unnecessary costs and delay

Upon completion of this training, you will be able to correctly and successfully:

• Comprehend the different types of regulatory pathways for obtaining regulatory approval of clinical studies with medical devices in The Netherlands

• Understand which documents are needed for the application from start to finish

• Adapt your procedures to the new requirements of the MDR/IVDR

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Lorem ipsum dolor sit amet, consectetur adipisicing elit. Autem dolore, alias, numquam enim ab voluptate id quam harum ducimus cupiditate similique quisquam et deserunt, recusandae.
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If you’re not 100% satisfied with the training within 14 days, I will offer you a full refund.


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Take the full 14 days to explore the materials and experience the vibe of the Training and THEN... make a decision using the information YOU HAVE, rather than the information you don’t.