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.

We would be pleased to show you our software solution «VigilanX» - make an appointment today.

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

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.

E-Mail

E-mails can be created and sent.

Dashboard

Information System:

Our Blog

Post-market surveillance (PMS) system of the manufacturer

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...

MDR Compliance Process

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...

Impact of the MDR on Quality Management Systems (QMS)

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...

Testimonials

  • 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