Case management
A complete new approach to keep track of complaints.
Monitor the progress of activities and optimise processes.
Go Beyond Without Compromise
Imagine case management done right:
Documents, images, videos, graphs, decision tree, analysis, EU-documents at your fingertips, using a multi-platform solution.
Optional: Web module
Regulatory requirements
of the EU and an automatic generation of manufacturer incident report EU form (PDF).
Company and regulatory requirements
Obtaining a CE mark requires that manufacturers establish and maintain a post-market surveillance process. This means PMS is required regardless of the classification of the medical device.
Headquarter
All the relevant data is managed, evaluated and transmitted to the authorities.
One Tool For All
A central tool for data collection, evaluation and communication with the authorities.
Four steps:
1. Complaint Intake
2. Regulatory Reporting
3. Investigation
4. Complaint Closure
Web module
Acquisition of data in the subsidiaries and from employees in the field with «VigilanX-WEB».
Worldwide data acquisition
Field staff in the field can easily enter complaints via browser on a tablet.
Data entered here can be transferred to the main module (headquarter) at the click of a button.
Call +41 79 321 23 06
We would be happy to present «VigilanX» to you remotely via “AnyDesk” or come and visit you.
Problems Are There To Be Solved
We Offer You The Right Tool For Your Needs
More Info
VigilanX & VigilanX-WEB
VigilanX is a Complaint Management & Reporting Solution for MedTech Companys.
VigilanX software is evaluated a unique & trendy solution for MedTech companies with a clean and modern design. Focused on complaints, VigilanX will make your work fluent and easier to do.
VigilanX Modules
Cases
Registration, assessment and validation of cases
Account
Central registration of hospitals, companies. Evaluation of cases according to accounts.
Contact
The employees of the corresponding companies, hospitals etc. are managed here.
Staff
Here you can manage the employees of your company. Various statistical evaluations round ….. round off.
Timesheet
The time spent by your employees in the context of the cases can be recorded here.Calendar
Planning of activities etc.
Documents
Central storage of all relevant documents.Tasks
List of tasks that must be completed.
Assets
Management of your products, manuals, instructions etc.Notes
Notes management.
Preferences
Management of access rights and passwords. Setting the master data.Milestones
Recording of milestones.
Audit Log
Logging of the recorded data.To-Do's
Managing your To-Do’s.
Dashboard
Information System:
Our Blog
The PMS system must be documented and implemented within the manufacturers’ QMS. The PMS should be risk-based according to the products manufactured. The PMS system must be suitable to gather, record and analyse the relevant data. It should be done in accordance with the control strategy of the manufactured product...
Below you will find a general process for MDR Compliance. There are amended and new classification rules. Some producers might find their products grouped in higher risk classes under the MDR. There will be an extended version of the Essential Requirements, now called the General Safety and Performance Principles or...
All medical devices, whether currently certified to a European Medical Directive or yet to be certified, will need to comply with the requirements of the MDR to be certified under the MDR. The MDR requires manufacturers to demonstrate an effective QMS. Therefore, to receive certification to the MDR, you must...