FSQ Experts - A Brand of Wertefest GmbH

Short description

As experts in functional safety and quality management, we are your partner for customised and practice-oriented solutions in the field of medical technology. We support you in case of bottlenecks in the areas of quality management, regulatory affairs or system engineering.

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Range of products

  • S Regulatory affairs
  • S Documentation
  • S Consulting
  • S Approval
  • S Continuing education/training
  • S Quality assurance, quality control

About us

FSQ Experts – we love technology, we speak regulation

As experts in functional safety and quality management, we are your partner for customised and practice-oriented solutions in the field of medical technology. We help you to effectively overcome bottlenecks in quality management, regulatory affairs or system engineering. We support you in expanding your expertise and overcoming resource bottlenecks.

Our customers manufacture innovative medical devices in line with megatrends such as robotics, AI technology and IoT. The high demands on quality and safety require a systematic approach in order to successfully master the complexity of this challenge. In addition to technological advances, companies are faced with the challenge of bringing medical innovations to the market in a timely and safe manner, despite the rapidly changing medical technology regulations worldwide. With our practical support, we actively help to achieve these goals together with our customers. At the same time, we help to establish or further develop a culture of quality and safety in their companies.

We support you:

  • bring innovative medical devices to market safely and in compliance
  • Increase the expertise of the development, quality and product management teams
  • Achieving sustainable conformity