Regulatory Affairs

Accelerate and simplify time to market by utilizing novel in-silico capabilities in the V&V process of your medical device. We provide training according to ASME V&V40 and FDA Guidance 1807.

Anatomy Studies

Apply anatomy studies and population based engineering to treat the maximum number of patients or support clinical trials with proper patient selection. Visit for more informaiton.

Company Building

You need support to build your digital health pipeline? We give guidance, from concept to regulatory approval. Especially in the domain of patient-specific implants/planning and in-silico applications.


Join one of our seminars or book an individual workshops about "Simulation in the approval process of medical products" together with our partner CADFEM Medical. Learn more about theoretical and practical foundations for the application of computational modeling and simulation in the conformity assessment, model verification and validation according to ASME V&V40 and the technical documentation according to FDA 1807.