One of confinis’ key competencies lies in the design control procedure for medical devices as well as combination products. 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), and MDD (medical device directive).
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.
Why is it important?
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.
