By end of 1998, the first European quality and safety requirements for in vitro diagnostic medical devices, the European Directive 98/79/EC (IVDD), stepped into effect. After almost 20 years in
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.