Start-ups often perceive processes and documentation as obstacles that slow things down. Companies usually regard them as an impediment to flexibility. Andrea Wildhaber and Felix Westhoff are convinced that both
In vitro tools that support medical diagnosis and treatment decisions are highly complex. In addition to increased scientific and engineering complexity, in vitro diagnostic tools undergo a lengthy regulatory approval process that includes complex factors during development and market launch, and also throughout the entire product life cycle. We have many years of experience in successfully developing, launching, and maintaining cutting-edge diagnostics for regulatory markets around the globe.