Medical Product Development: Systems Engineering
KMC's systems engineering team plays a leading role in every medical device development project througout the Total Product Lifecycle. This begins with assuring that the product requirements are accurately documented prior to design so that the developed product will meet the intended use. As the architects of the medical devices and instruments that we design, our systems engineers are responsible for:
- The definition, documentation and control of requirements.
- Lead the hardware/software architecture concept definition for appropriate technologies and implementations are selected.
- The planning, definition, documentation and control of risk management and hazard analysis activities.
- The planning, definition, and documentation of all systems verification and validation activities
Hardware/Software Architecture Concept Definition
The development of medical device design concepts and system hardware/software architecture is critical. Our team identifies design concepts, and evaluates each for its compliance with requirements. This ensures a successful market introduction.
Concepts selected for refinement by the customer undergo further development. KMC Systems’ system engineers coordinate this activity and perform system-level analysis of critical functions and performance. This analysis can include the following:
- system timing and throughput
- feature/instrument performance simulation
- critical interfaces and tolerances
- thermal/optical performance
- process control tolerances and algorithms
Risk Management and Hazard Analysis
According to the ISO 14971 standard, all medical devices require a risk analysis. This is a core function of our systems engineering group. At KMC Systems, the risk management process starts at the onset of the product design project and carries through development into production and into post-market. Hazard analysis includes techniques such as Failure Mode Effects and Criticality Analysis (FMECA or FMEA) and Fault Tree Analysis (FTA).
Our systems engineering team is well-versed in both system and software analysis. With a thorough understanding of the Total Product Lifecycle from concept to the end use of the medical systems we design, we can rapidly identify any potential safety or use error risks. Then, using industry-recognized processes, we create risk control measures to intelligently mitigate these risks. Our detailed quality and risk management process with integrated hazard analysis meets the requirements of the FDA’s Quality Systems regulation and respective International standards.Top of Page
System Verification and Validation
For medical devices and instrumentation, verification and validation are required to bring products to market. At KMC Systems, we understand these requirements. Our proven process provides verification traceability from design input to product output. Our design control and manufacturing processes then provide product suited for validation.
While verification takes place toward the end of the product design cycle, our preparation efforts begin on day one. We implement rigorous design controls to ensure that product designs meet manufacturing requirements. Conduct and document technical reviews happen throughout the entire engineering process. Every defined requirement is satisfied.
Reliability verification is not required by the FDA; however, KMC Systems goes above and beyond. Upon request, we can provide verification of system and/or module reliability via analysis or testing. KMC Systems’ expertise in electronics and software architectures often enables module reliability testing to begin early in the development cycle. This provides more efficient design feedback before reaching the verification phase.
Afterward, our customers validate the product through user testing. For validation, we assist customers through provision of comprehensive design history files, including technical data required for regulatory approval from drawings of critical parts to source code listings. We can also provide consultation upon request.