Qualitiso • Regulatory Affairs and Quality for Medical Devices
Welcome to Qualitiso
Since 2014, Qualitiso has helped medical device professionals move faster on regulatory and quality matters.
Our Services
Three ways to save time on regulatory and quality matters
Qualitiso brings together expert content, structured templates and a specialised AI assistant to help RA/QA teams work faster, more systematically and with less fragmentation.
Keep track of the regulatory and standards developments affecting your medical devices more easily, without having to monitor multiple sources.
- Read expert analysis to quickly understand new developments and their impact.
- Use automated monitoring that can be configured according to your needs.
- Access structured monitoring of 287 news sources and 233 standards committees.
- Identify important publications relevant to your activities more quickly.
- Add your own sources on request for even more targeted monitoring.
Save time on your regulatory and quality work with templates designed to structure your documents, address key requirements and reduce the risk of omissions.
- Build your Quality Management System on a more structured foundation.
- Organise your Technical Documentation more systematically.
- Prepare the CE marking of your medical devices more efficiently.
- Benefit from 89 templates covering 3,800 requirements and 639 parameters, along with thousands of examples, comments and definitions.
QualitiBot is an AI assistant specialised in RA/QA, designed to help medical device professionals analyse, structure and draft content more quickly.
- Analyse a regulatory topic or document faster.
- Structure an outline, framework or deliverable more clearly.
- Create a usable first draft in just a few minutes.
- Use your documents, projects and library to generate more contextualised results.
- Rely on an assistant designed specifically for the regulatory and quality challenges of medical devices..
