We help you with your complaints

Our Team

Responsible for programming.
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    Owner of MacTech Ltd and programmer

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    Project manager and programmer

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    Programmer & Visionary

Team Together

Our talents
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    Legends are there to inspire you. Responsible for sale and support.

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    S. FREY

    Responsible for the back office.

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    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


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    Dashboard Panel

    View your top risks and management actions in the snapshot dashboard view

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    Identify Risks & Report them

    Quickly identify and report

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    Demonstrate Compliance

    Demonstrate your compliance efforts with fast and comprehensive reporting

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    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.
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    Case Management

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

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

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    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
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    Analyse your data

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    Get your data displayed

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

Operational worldwide

Thanks to «VigilanX-WEB», complaints from your branch offices or your sales representatives can be recorded any time worldwide.


Worldwide complaint handling at any time
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    Eiffel Tower


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    Taj Mahal


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    Statue of Liberty


Power lies in Simplicity

Interconnected thinking and acting from anywhere on any platform


VigilanX-WEB on iPhone and iPad  |  VigilanX on MacBook Pro, iMac or Windows Computer