With more than 20 years of experience developing Class III medical devices from concept to clinical and finally to market, our team is capable of helping in all aspects of the development process.
All of the medical devices we develop begin and end with one question: How do we provide the patient with a safe and effective product?
DesignPlex follows an ISO 13485 certified risk-based design approach to designing medical devices that allows us to mitigate any product issues from the start. This happens even before hardware, schematics, or prototypes have been created, helping to reduce overall costs and lead times in the later stages of the project. We play a key role in systems engineering so all components of the device are integrated and aligned with the final product requirements.
The DesignPlex team has more than 20 years of experience helping our clients bring their medical devices through clinical trials. We help you navigate the regulations and design the verification and validation plan for a smooth regulatory path - whether it is for First-In-Human, pivotal study, or commercial supply. We make sure your Design History File will support your product and indication making for a smooth regulatory pathway.