Complaint Management

VigilanX

We help you with your complaints

Our Team

Responsible for programming.

PAVEL BUNCAK

Owner of MacTech Ltd and programmer
STEPHAN SCHMIERER

Project manager and programmer
JAOHANNES THALHAMMER

Programmer & Visionary

Team Together

Our talents

CHRISTIAN SEMLITSCH

Legends are there to inspire you. Responsible for sale and support.
S. FREY

Responsible for the back office.

Vigilance and Post Market Surveillance (PMS)

Under the new Regulation 2017/745, device manufacturers will be required to collect post-market clinical data as part of their on-going assessment of potential safety risks. Post Market Clinical Follow up (PMCF) is a continuous process with the objective of constantly updating the clinical evaluation.
Additionally, reporting timeframes are tightened from 30 days to 15 days for reporting serious incidents.There will be new electronic vigilance reporting and Periodic Safety Update Reports (PSUR) for all devices subject to differing frequency and submission requirements.

Signiﬁcant changes in the Medical Device Regulation and their Implication for Manufacturers

The MDR is a fundamental revision of the earlier Directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.

It is important to note that the Regulation has binding legal force throughout the EU and enters into force simultaneously in all the Member States.

Respond to emergency situations fast

Problems are to be identified and solved with the right tool

«VigilanX»

Dashboard Panel

View your top risks and management actions in the snapshot dashboard view
Identify Risks & Report them

Quickly identify and report
Demonstrate Compliance

Demonstrate your compliance efforts with fast and comprehensive reporting
At the customers premises

Field staff can record complaints (iPhone Plus or iPad) directly at the customer’s premises, take pictures and log them by using VigilanX-WEB

Complaint Management & Regulatory Reporting

At MacTech, our mission is to provide elegant technology solutions that improve collaboration and decision making for healthcare users.

Case Management

Keep track with complaints. Monitor the progress of activities and optimise processes.
Headquarter

One central solution for all the relevant data to be evaluated and transmitted to authorities.
VigilanX-WEB

Get the complaints entered in the field by your representatives / employees at any time any where in the World using a browser.

Complaint Management & Regulatory Reporting

Problems Are There To Be Solved.
We Offer You The Right Tool For Your Needs.

Our Solution is your success

Reduce your time and ensure the quality

Dashboard

Analyse your data
Chart

Get your data displayed
VigilanX-WEB

Get the complaints entered in the field by your representatives / employees at any time any where in the World using a browser