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Small Walt Question: My company is developing a complex disposable cartridge for a point-of-care technology, and will hire a medical contract partner to design and  manufacture the instrument itself. At what point should we engage a medical device contract manufacturer?Answer
Small David Question: I want to implement  a lean medical product manufacturing philosophy into  my business. What are some of the  challenges we can expect to  face? Answer
Small Ed Question: The pressure to introduce new medical devices to market quickly and cost-effectively is constant. What strategies can I employ to commercialize my product in a strict timeframe? Answer
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Requirements Definition

KMC Systems: Validating Requirements Definition

The requirements definition is the foundation of any medical device design project; and when you work with KMC Systems software, mechanical and electrical engineering teams, you'll experience superior system performance, cost-effectiveness, and end-user satisfaction.

We closely coordinate the development of the systems requirements with the software requirements and risk management process activities. This leads to mechanical, electrical, and software functionality.

From the system level, we drill down to the module level requirements and medical device design documents. This ensures all details necessary to meeting the requirements are documented, including

  • architecture
  • operating principles
  • design rationale

To see how the KMC360® Rapid Product Development process turns smart ideas into brilliant reality, learn more about our Total Product Lifecycle philosophy or download our Total Product Lifecycle Chart. 

Download TPLC Chart