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Medical Devices

The Future of Standardization in Medtech and Its Impact on Your Regulatory Compliance

Tuesday, May 7, 2024
13:45 – 14:45 CEST
Location: B 09
Learning Level: Expert
Description: The digitalization of processes and information has also begun in the Medtech industry and will massively change the work of regulatory affairs experts in the coming years. The key to the benefits of digitalization and the seamless integration of different software systems and platforms is the use of so-called "structured content" and common data formats. There are two important future data formats for standardization in the Medtech industry:

1. The international cross-industry "SMART" standard format will change the creation of standards, the management and application of included regulatory requirements, as well as the efficient integration into medical device development. The German standardization organization DIN e.V. and its publishing company DIN Media (previously Beuth Verlag) has been involved in this project from the beginning and will provide an overview of the status quo as well as already available digital services.

2. A Medtech specific data model for content of the EU MDR technical documentation is currently under development, coordinated by the nonprofit association Medical Device Knowledge Units (MDKU) e.V. Benefit of this data model will be a clearer regulatory language as well as acceleration of digitalization particular in the Medtech industry.

Learning Objectives:

  • Understand the potential of digitalization of regulatory processes for regulatory affairs: the transformation from a document to content centered information management
  • Learn about upcoming new data formats for standardization in Medtech: • International industry independent SMART standards • European Medtech data model for content of the EU MDR technical documentation
  • Get an overview of already available digital services for standard related data
  • Utilize your knowledge about benefits of digitalized information management for your strategic decisions on the way to increased efficiency, regulatory compliance and competitive advantage.