In brief: ASME V&V40 is the standard for establishing that a computational model is credible enough to support a medical device decision. Compliance involves defining the question of interest and context of use, assessing model risk, setting credibility goals proportionate to that risk, generating the corresponding evidence, and documenting the

The medical device industry faces many challenges and pressures to reduce development timelines, cut costs and navigate complex regulatory pathways. Traditional development approaches rely heavily on animal testing and extensive clinical trials – processes that can take years to complete and many iteration loops due to failed trials. With new,

Pediatric cardiovascular medical device development faces a critical challenge: children are not just “small adults.” Their unique anatomies, rapid growth, and vulnerable physiology create hurdles that traditional research and testing methods struggle to overcome. Small patient populations, ethical limits on clinical trials, and high development costs leave most companies focusing

When One Size Doesn’t Fit All Medical devices should work for everyone—not just for a narrow group of patients. True inclusive medical device design means creating solutions that fit people across age, sex, size, and anatomy. Yet too often, devices are designed and tested on limited datasets, which can lead

Bringing digital twinning software into your medical device development process can seem complex at first. The technology might feel abstract, and introducing new software into your workflow may put you off. However, our team of experts makes sure you are guided through the whole process and can start using the

As regulatory frameworks evolve and digital health technologies advance, in silico methods like modeling, simulation, and virtual clinical trials are increasingly positioned to transform cardiovascular device development. In silico clinical trials for cardiovascular devices are high on the list of priorities for regulators such as FDA. Still, despite clear advantages,