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.

In silico Clinical Trials

Use virtual patients and simulation for performing in silico R&D and clinical trials to bring medical devices faster and more cost-efficient to the market. 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.