A major leap forward in the development of medical technology
Simulation in the
approval process
Apply simulation in accordance with the latest guidelines and standards in a regulatory-compliant manner – so that you can fully exploit the potential of simulation. We accompany you with experience and know-how to support you in the approval of your medical device with state-of-the-art simulation techniques.
Benefits for you
Faster approval through in silico tests
Better risk management using ASME approved processes
Objective evidence of product performance and safety for technical documentation
The future of medical technology
Computer modeling and simulation have proven their value in highly complex and critical technology sectors such as aerospace, chip design, and power engineering. These reliable simulation methods have the potential to revolutionize medical device approval by reliably replacing in vitro and in vivo testing with in silico testing.
In the future, the use of ethically difficult animal and human testing will be shifted to the level of virtual test setups including virtual patients, providing early opportunities to safely test and adapt product developments. Accelerated medical device approval will thus be possible and can also be planned in terms of time.
Our offer to you
- Training and support for risk assessment of simulations according to ASME V&V40 and ISO 1497
- Training and support to create and execute a V&V plan for simulations following ASME V&V10 and ASME V&V40
- Training and support regarding FDA-compliant reporting of simulations according to FDA 1807
- Project work and simulation support to generate objective evidence for verification and validation of medical devices
