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Introduction to risk management for medical devices permit to have the general overview of ISO 14971 requirements

TM_001_01 rev 01

At the end of the training, a questionnaire must be completed by the employee (hot evaluation).
If they obtain the training certificate, we consider that they are autonomous to carry out these tasks.
If you don't get enough points, further training will be organised with the responsible of this training.

No cold assessment is necessary.

Electrical safety of medical device :
- EMC (Electromagnetic Compatibility)
- ESD resilience
- Electronic and envelop design requierement
- Power supply resquierement

At the end of the training, a questionnaire must be completed by the employee (hot evaluation).
If they obtain the training certificate, we consider that they are autonomous to carry out these tasks.
If you don't get enough points, further training will be organised with the responsible of this training.

No cold assessment is necessary.

TM_001_Risk Management rev 01

This training explains the different requirements expected from ISO 14971:2019.
This training is in several stages:
- Risk management process
- Risk analysis
- Risk Assessment (estimation + evaluation)
- Risk control

At the end of the training, a questionnaire must be completed by the employee (hot evaluation).
If they obtain the training certificate, we consider that they are autonomous to carry out these tasks.
If you don't get enough points, further training will be organised with the responsible of this training.

No cold assessment is necessary.

Six Sigma gives you the tools and techniques to determine what’s making the manufacturing process slow down, how you can eliminate the delays, improve the process, and fix further issues along the way. It is a methodology that has seen worldwide adoption.

At the end of the training, a questionnaire must be completed by the employee (hot evaluation).
If they obtain the training certificate, we consider that they are autonomous to carry out these tasks.
If you don't get enough points, further training will be organised with the responsible of this training.

No cold assessment is necessary.

Cette formation est une introduction au RGPD. Elle décrira dans les grandes lignes à quoi sert ce règlement et qui sont concernés.

À la fin de la formation, l'employé doit remplir un questionnaire (évaluation à chaud).
S'il obtient le certificat de formation, nous considérons qu'il est autonome pour effectuer ces tâches.
S'il n'obtient pas assez de points, une formation complémentaire sera organisée avec le responsable de cette formation.

Aucune évaluation à froid n'est nécessaire.

This course explains the FDA's role in the regulation of medical devices. It provides the definition of a medical device and describes the steps involved in bringing a new product to the US market, as well as the different types of pre-market regulatory submissions that may be required by the FDA.

At the end of the training, a questionnaire must be completed by the employee (hot evaluation).
If they obtain the training certificate, we consider that they are autonomous to carry out these tasks.
If you don't get enough points, further training will be organised with the responsible of this training.

No cold assessment is necessary.