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Management System Support

We can help you with support, education and training within:

  • ISO 9001 -> Quality management systems
  • ISO 13485 -> Medical devices - Quality management systems - Requirements for regulatory purposes
  • FDA Title 21 Part 820 - Quality System Regulation
  • ISO 14971 -> Medical devices - Application of risk management to medical devices
  • ISO 62304 -> Medical device software - Software life-cycle processes
  • ISO TR 80002-2 -> Medical device software - Part 2: Validation of software for medical device quality systems
  • ISO 27001 -> Information Security Management Systems
  • FDA Title 21 Part 11 - Electronic records, Electronic signatures
  • ISO 14001 -> Environmental Management
  • ISO 45001 -> Occupational health and safety management

group of people holding and smilingMore than 20 years of experience

You gain access to more than 20 years of experience in building, implementing and operating management systems in both small and large companies within service, development and production.

Increased earnings

You will be helped to build, implement and operate effective management systems that works in daily practice without being a drag. Management systems is a great tool for eliminating risk, defects and deviations and bad customer experiences and thereby increasing customer satifaction, employee satisfaction and in the end company earnings.

Attractive prices

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

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

  • Wismatix QMS Manager
    - complete management system with X number of users based on your company size
  • Implementation/Optimization/Updating
    - your existing system is optimized, updated and implemented in Wismatix QMS Manager
  • Internal audits
    - planning in cooperation with you, execution and reporting
  • Supplier audits
    - planning in cooperation with you, execution and reporting
  • Management reviews
    - planning in cooperation with you, execution and reporting

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