Usability training
I offer in-house training to help teams understand, structure and implement a usability process that complies with the requirements applicable to medical devices.
The programmes combine methodological input, lessons learned, exercises and role-play scenarios adapted to your products. The goal isn't just to understand the standards, but to know how to apply them concretely to your projects.
IEC 62366-1 · IEC/TR 62366-2 · IEC 60601-1-6 · ISO 14971 · MDR · IVDR
On-site or remote
Up to 10 participants
Exercises adapted to your devices
In-house training
CHOOSE YOUR FORMAT
Discover the fundamentals, implement the entire process, or dive deeper into preparing a summative evaluation: each programme addresses a different need.
Training - 1 day
One day to understand the essential requirements of IEC 62366-1, structure the process and identify the main deliverables expected under the MDR and IVDR.
1 day · 7 hours · €1,200 excl. VAT
For teams discovering the process or wanting to align their practices.
See the 1-day programmeTraining - 2 days
Two days to explore the entire process in depth, work on the main deliverables, and practise use-related risk analysis as well as preparing formative and summative evaluations.
2 days · 14 hours · €2,200 excl. VAT
For teams that need to implement or strengthen their usability process.
See the advanced programmeHands-on workshop
A focused workshop to scope a summative evaluation, build a protocol consistent with use-related risks, and anticipate the points that most often weaken studies.
Duration and price on request
For teams preparing a summative evaluation who already have an IEC 62366-1 foundation.
Discover the summative workshopCOMPARE
| Your need | 1 day | 2 days | Summative workshop |
|---|---|---|---|
| Understand the IEC 62366-1 process | ✓ | ✓ | Prerequisite |
| Identify the main deliverables | ✓ | ✓ | Summative-focused |
| Practise use-related risk analysis | Introduction | In depth | As needed |
| Work on formative evaluations | Introduction | In depth | - |
| Build a summative strategy | Introduction | In depth | Core of the workshop |
| Work on your own device | Adapted examples | Full exercises | Focused work |
| Benefit from exercises and role-play scenarios | ✓ | ✓✓ | ✓✓ |
PROGRAMME DETAILS
APPROACH
The training sessions are delivered directly by Amandine Broussier, a usability specialist for over 10 years. They draw on experience gained with more than 50 manufacturers and on numerous user tests conducted or analysed throughout her career.
Real situations, concrete examples and answers directly connected to manufacturers' constraints.
Exercises and examples are tailored to your devices, your users and the maturity level of your process.
Questions, exercises, case studies and role-play scenarios to encourage teams to take ownership.
Methods, habits and tools that participants can reuse as soon as they return to their projects.
The goal isn't just to understand the standard, but to know how to apply it concretely to one's own projects.
SATISFACTION
4,9/5
Average rating of evaluated sessions
100 %
of respondents recommend the training
Exercises adapted to the products · Concrete examples · Clear definitions · Case studies
Data from satisfaction surveys available to date.
The training is designed for people involved in the development, quality, regulatory or evaluation of medical devices:
Regulatory affairs · Quality · R&D · Project managers · Product managers · Engineers · Founders and project leads
The training is offered in-house, on the client's site or remotely, for groups of up to 10 participants.
The content can be adapted to the participants' level, the type of device, and the challenges faced by the company.
I work in partnership with a training organisation certified under the Qualiopi quality standard.
Training provider registration number: 32591325659.
This registration does not constitute state approval.
Let's discuss their current level, your devices and the real-world situations you'd like to include in the training.