More than 25 years of experience

You gain access to more than 25 years of experience in building, implementing, and operating management systems. For instance, both small and large companies within the service, development, and production fields can benefit from Wismatix. We will help you create a standard system that documents procedures, processes, and responsibilities for achieving quality policies and objectives. As a result, you will be able to manage your data like never before. Last of all, and most importantly, we want you to meet and exceed your customer’s expectations!

Millions of organizations around the world benefit from implementing QMS standards. However, time and effort are needed in order to establish and maintain this framework. We can help! For instance, you are likely interested in determining a way to measure customer satisfaction and manage documents and records. With Wismatix we can take the worry and stress away. Simply email us at and let us know how we can help you.

Quality, Environment, IT and CE

Medical Devices

  • ISO 13485 / FREE ISO 13485 standard available
    – Quality Management, Requirements for regulatory purposes

  • ISO 14971
    – Application of risk management for medical devices

  • ISO 62304
    – Medical Device Software, Software life-cycle processes

  • ISO TR 80002-2
    – Medical Device Software, Validation of software for medical device quality system

  • FDA Title 21 Part 820
    – Quality System Regulation

  • FDA Title 21 Part 11
    – Electronic records, Electronic signatures

Increased earnings

You will be helped to build, implement, and operate effective management systems that will work in your daily practice without being a drag. In addition, you will have more time to spend on your customer’s needs.

Organizations that adopt the Wismatix QMS can enjoy many benefits. For instance, you will see improved internal controls, leadership emphasis, lower costs, higher prices, greater opportunities in the marketplace, minimize waste, more satisfied customers, less litigation, and so on.

Management systems, and in particular Wismatix QMS, are an excellent tool for eliminating risk, defects and deviations, and bad customer experiences. After that, you will see an increase in customer satisfaction, employee satisfaction, and in the end, company earnings.

Attractive prices

If you choose Wismatix QMS to run your management systems, you’ll get access to our most advantageous consultancy prices.

You can choose to get a complete offer for operating your management systems containing:

  • Wismatix QMS
    – complete management system with X number of users/employees based on your company size

  • Implementation/Optimization/Updating
    – your existing system is optimized, updated, and implemented in Wismatix QMS

  • Internal audits
    – planning in cooperation with you, therefore improving your execution and reporting

  • Supplier audits
    – working with your team in order to aid in improving your company’s performance

  • Management reviews
    – reviews in cooperation with you to aid with execution and reporting