Regulatory Affairs Office

Many different stakeholders accompany the development of a medical device from its idea to its implementation in the healthcare sector. All these stakeholders have different targets: most innovative medical devices, fastest and most cost-effective market entry or maximum benefit for medical professionals. However, the regulatory requirements are usually not taken into account while achieving these targets. Most of innovative project ideas and their resulted medical devices cannot be placed on the market because the required documentation for market clearance is missing. Furthermore, a follow-up documentation might be too time and cost-intensive.

For this purpose, the Regulatory Affairs Office of the EKFZ supports project teams on regulatory issues. This support is provided throughout the entire project duration in order to avoid extensive post-project documentation or even the termination of the project. The Regulatory Affairs Office helps turning innovative project ideas into marketable medical devices, thereby saving time and money.

To ensure an optimal support, a quality management system according to DIN EN ISO 13485:2016 will be established and implemented.

• Training on Regulatory Affairs in the field of medical devices
  • Basics of EU legislation on medical devices
  • Basics of quality management for medical devices
  • Required steps and documentation within the development of medical devices

• Regulatory support of the project teams during research and development of medical devices
  • List of required documents referred to the respective project
  • Raise awareness of writing documents for the technical documentation
  • Writing of regulatory specific documents for the technical documentation
  • Contact for regulatory related questions

These services are provided for our Interdisciplinary Innovation Project-Teams funded by the EKFZ for Digital Health as well as for externals focusing on digital health.

For Interdisciplinary Innovation Project-Teams funded by the EKFZ for Digital Health: all regulatory support is included.

For support from Dresden concept an initial consultation is included, further consultations are fee-based.

For Externals: any consultations are fee-based.