Medical
The Challenge
The success of a quality digitization project in the medical sector hinges on several key factors:
- Medical standards management : ISO 13485 and CFR 21 Part 11 are demanding, and you need an application built to meet them without compromise. Our teams are on hand to provide you with all the documentation you need to respond to your auditors with ease.
- Accompaniment : Our specialist medical consultants will answer your questions, help you draw up the documentation and accelerate solution deployment.
- Application ergonomics : Just because operators are qualified doesn't mean they can't have an easy-to-use application.
- Authorization management : Only authorized operators are allowed to work on the controls, avoiding any unqualified intervention and potential errors.
- Continuous availability : Ellistat ensures 99.9% availability, guaranteeing uninterrupted operations.
With these features, Ellistat is the ideal choice for successfully digitizing quality in your company.
Thanks to Ellistat software you'll be able to meet many of the requirements of ISO 13485 and CR21 Part 11
Real-time production monitoring
View all your production data on a single page. Automatically create control charts by connecting your shop floor measuring instruments.
Non-conformities
Track all non-conformities in your company via a centralized platform.
Traceability
Find in a few moments any batch manufactured by machine/operator/measuring instrument/... and create a customized report to meet your customers' most precise requirements.
Compliance with ISO 13485 and CFR 21 part 11 standards
We can help you to validate your quality software with complete peace of mind.
Closed Loop Manufacturing
Set your machine tools automatically and no longer depend on the expertise of your setter to guarantee your output quality.
Workshop communication
Display your workshop's key information, customize and manage your KPIs with our shareable dashboards.
Authorization management
Limit access to what's strictly necessary, and manage access rights to ensure that an operator is authorized to create/modify the document.
Discover our proud Ellistat clients
Azurea
Medical / Watchmaking
Ellistat's APC module has enabled us to produce just the right quality. For some parts, we went from 6 checks to just 3 a day.
Bien Air
Medical
Bien-Air Surgery achieved efficiency by optimizing its QC with Ellistat's IQC Module.
LISI
Automotive / Aerospace / Medical
95% reduction in scrap rate, 75% reduction in machine tool set-up time using APC.