One of our successful design projects involved a client who had a concept for a new medical device but had limited experience with product development and regulatory approval processes. The client approached us for assistance, and we worked closely with them to understand their requirements and ensure compliance with regulatory standards. 

We began the project by conducting a product risk assessment to identify and mitigate potential hazards associated with the device. Once the risks were identified and mitigated, our team designed the components of the device and created prototypes for testing. The prototypes were subjected to benchtop testing and user testing to ensure that the device met both regulatory and customer requirements. 

After finalising the design, we assisted the client in sourcing manufacturers and designing for manufacture. Our regulatory team also created the technical file required for regulatory approval, ensuring that the development process followed ISO 13485 and 21 CFR 820 requirements. 

Thanks to Vestech’s expertise, the client’s medical device was approved by regulators and was able to be commercialised successfully. Our ability to work with the client to obtain regulatory approval and its expertise in product development and compliance reduced the time to market for the client’s product, resulting in a successful partnership.