How do you manage your Quality Management System? If you are like the majority of the medical device industry, chances are you have a QMS that is a combination of paper-based processes and general purpose tools, loosely held together by a group of people within your company–usually document control. Maybe you are using Excel or a self-made software solution that does not integrate all data?

The best way to describe this approach to a QMS is ad hoc. I mean no disrespect if this is your method. It can work. But it is full of risks. Risks of relying on tools that don’t scale. Risks of inefficiencies. Risks that QMS knowledge lies solely with the people managing the day to day.

Out of practice for practice:

In cooperation with the company Mathys Ltd in Bettlach, I and my team created the software solution «VigilanX», which meets the requirements in the EU. «VigilanX» simplifies the daily work and optimizes the processes, archives the data, plans necessary measures, schedules them, evaluates the data and displays them graphically. All this is supplemented by the Internet tool “VigilanX-WEB”. Employees in your branches and employees at your customers as well as your representatives can enter complaints in theWEB module.

Simply put, without a professional software solution you will not be able to meet the requirements anymore!

«VigilanX» is a purpose-built solution for the medical device industry that addresses compliance, allowing you to better focus on developing high quality products through streamlined processes. Bottom line: This approach allows you to put emphasis on what is best for the patients who receive your life-saving technologies.

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