Our expertise in the medical sector
Contact usThe 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 that is built to meet them without compromise. Our teams are on hand to provide you with all the documentation you need to answer your auditors' questions.
Support
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.
Availability
continues
Ellistat ensures 99.9% availability, guaranteeing uninterrupted operations.
Authorization management
Only authorized operators are allowed to work on the controls, avoiding any unqualified intervention and potential errors.
With these features, Ellistat is the ideal choice for successfully digitizing quality in your medical sector company.
Responding to specificationsEllistat Quality Software Suite
Designed to meet the specific needs of the medical industry
Real-time production monitoring
View all your production data on a single page, in real time. Automatic calculation of quality indicators (Cp, Cpk, Pp, Ppk...), alerts in case of deviations and root cause detection.
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 case studies
LISI
Automotive / Aerospace / Medical
95% reduction in scrap rate, 75% reduction in machine-tool set-up time with ...
AZUREA
Medical / Watchmaking
Ellistat's APC module enabled us to produce just the right quality. For certain parts, we went from ...
Bien Air
Medical
Bien-Air Surgery optimizes its control efficiency with Ellistat's IQC software solution.
