Your catheter concept is fine-tuned, improved, and optimised with a view to achieving a Design Freeze specification. In design realisation we can consider all elements in the design lifecycle if you require, including:
- Handle design
- Accessory devices
- Packaging design
- Sterilisation requirements
- Manufacturing methods & DFM.
The design is characterised, challenged, and stressed to failure, giving us a clear insight into what it can and cannot do.This enables us to flag potential risks and whether these need to be addressed before moving forwards. In testing, the catheter design is challenged; here in our labs, in your labs, in cadavers, in animal trials and GLP. The objective is to design, develop and test your device to achieve a robust and efficient design freeze specification ensuring it has the optimum confidence to successfully meet its testing requirements in any subsequent design verification and validation testing program. We look at the total solution for your product in the context of the overall system, we consider DFx (design for x) and very specifically DFM (design for manufacture). This enables us to flag potential risks and whether these need to be addressed before moving forwards. In testing, the catheter design is challenged; here in our labs, in your labs, in cadavers, in animal trials and GLP. The objective is to design, develop and test your device to achieve a robust and efficient design freeze specification ensuring it has the optimum confidence to successfully meet its testing requirements in any subsequent design verification and validation testing program. We look at the total solution for your product in the context of the overall system, we consider DFx (design for x) and very specifically DFM (design for manufacture).