GAMMA Workshop

GAMMA workshop 18th March 2026 09:00 AM- 13:00 PM at Ditze-Hall

Block 1: Regulatory Requirements and Clinical Gait Analysis

  • 09:00   Regulatory Framework in Clinical Gait Analysis with a Focus on the Medical Device Regulation (MDR)
    Dr. Scherer, Federal Office for Safety in Health Care, Vienna
    Focus: MDR requirements for clinically used gait analysis systems (including software)
  • 09:40   Prosthesis Registry Heidelberg: Real-World Data on Quality of Care
    Prof. Sebastian Wolf, University of Heidelberg
    Focus: Health services research & registry data as evidence base for approval & demonstration of effectiveness
  • 10:00   How much evidence does the MDR require – and how can clinical practice provide it?
    Discussion
  • 10:15 Coffee break

Block 2: Musculoskeletal Simulation as a Tool for Demonstrating Effectiveness

  • 10:45  Musculoskeletal Simulation to Assess the Effect of the Agilium Freestep Orthosis on the Load in the Medial Knee Compartment
    Dr. Christina Frese, University of Stuttgart
    Focus: Use of models for mechanical-functional evaluation of orthoses
  • 11:05  Musculoskeletal Modeling in Orthosis and Exoskeleton Development: Proof of Function Without a Clinical Trial?
    Dr. Jörg Miehling, University of Erlangen
    Focus: Individualized simulations, application examples, regulatory relevance
  • 11:25  Demonstrating the Effectiveness of an Exoskeleton under Different Lifting Strategies on Lower Back Loading
    Dr. Thomas Schmalz, Ottobock Biomechanical Research, Göttingen
    Focus: From motion capture via inverse dynamics to force estimation using a musculoskeletal model
  • 11:45  How realistic must models be to be recognized by regulators?
    Discussion
  • 12:00 GAMMA General Assembly
  • 13:00  End of Workshop