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
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.
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.
1. Complaint Intake
2. Regulatory Reporting
4. Complaint Closure
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.
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...
The mind has great influence over the body, and maladies often have their origin there.
John Doe Molicere
There’s lots of people in this world who spend so much time watching their health that they haven’t the time to enjoy it.
John Doe Molicere