We employ balanced requirement and risk engineering principles to derive design inputs at system, subsystem and component level. Our multi-disciplinary engineering team is skilled in translating the design inputs into robust designs, taking reliability and manufacturability in consideration.

A systematic V&V planning and execution ensures that the product performs as per the design input specifications and as per stakeholders needs. We utilize multi-tier testing methodologies for product verification – spanning software and hardware sub-systems and their integration into full system - to ensure thoroughness and requirement coverage. We are also conversant with the needs of multiple types of regulations driven testing, like EMC & safety testing. Lastly, we can execute systematic usability and clinical validation at customer/hospital sites to ensure we meet business and regulatory needs.

Our team has extensive experience in developing and maintaining the Design History File (DHF) as per US FDA 21 CFR 820.30 and ISO 13485:2016 for the project at hand.

Design transfer is the process of ensuring that device design is correctly translated into production specifications. To this end, we identify part suppliers, design production processes, and plan & conduct process validations.