An effective and efficient design control procedure with an appropriate individual document management system provides plenty of support for the development of qualitative and highly valued products.
In addition, an elaborate design control procedure facilitates reductions in the costs of product development. It also supports audits by both internal and external bodies.
We will gladly support you through the creation and improvement as well as through the usage and auditing of your design control procedure. With our experience we can help you build an individually tailored and structured design control procedure that meets all regulatory requirements, such as GMP (good manufacturing practices), QSR (quality systems regulations), as well as EU MDR and EU IVDR requirements.
We cover the complete product development lifecycle, from the definition of user requirements to a verified, validated and registered product that can be marketed in different countries.
Risk management is a central process throughout the development and the entire product lifecycle. We will help you create a complete risk management file for your product by combining risk management with usability engineering/human factors and other normative requirements.
The creation or improvement of the risk management procedure, including the necessary forms and report templates, are just as important to us as the complete risk analysis. Thus, we facilitate the maintenance of the risk management file.