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
The industrialization of complex life science and diagnostic systems not only require architectural and functional development, production and testability must also be integrated.
Intensive alignment between development and production guarantees reliable and cost-optimized instruments and consumables after launch.This is important for series production of high-quality reliable products.
The synergy between production process requirements and functional needs, including modularization and testing, takes place in the industrialization phase. Here the groundwork is laid for the transition from prototype and pilot production to series production.