Certifications

Mandatory security training for all employees and consultants

The ISO 13485 standard: 2016 specifies requirements for the medical device and quality management system to be used by related medical device companies.

The implementation of an appropriate QMS is essential for medical device companies.The global regulatory requirements insist on this point and oblige the respect of these standards by the companies all over the world. Along with this need for implementation comes a need to understand the requirements.
The aim of this course is to clarify the application of ISO 13485: 2016 standards for companies of medical device development of the medical device.

In this course we are going to walk through the ISO standard for:
- Clarify on the concepts
- Show how it relates to business processes
- Elaborate on the practical application

You can learn what the requirements are and be familiar with best practice guidelines that will benefit your operations.
Furthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs.

Understand and implement a best practice quality management system in accordance with medical requirements.Get the information you need to design, and improve your company's QMS in accordance with ISO 13485: 2016.

What you’ll learn?
- How ISO 13485 requirements apply to medical device companies
- Requirements of the ISO 13485:2016 standard
- The importance of implementing a Quality Management System per ISO 13485:2016

Are there any course requirements or prerequisites?
- No specific prior knowledge is required
- Familiarity with quality management systems is helpful
- A general understanding of medical device life-cycle is useful
- Owning the ISO 13485:2016 standard is optional but recommended

Who this course is for:
- Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
- Professionals tasked with overseeing a management system meeting ISO 13485 standards
- Quality managers
- Risk managers
- Medical device practitioners interested in the ISO 13485 framework

This training is the induction to the Quality Management System and regulatory stand point.

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.

MDR (Medical Device Regulation (EU 2017/745)) is the new European regulation for medical devices. It replaces the MDD regulation.

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.

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.

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.

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.