Medical Product Design: Electrical Engineering

For 30 years, the KMC Systems electrical engineering team has designed electronics for complex medical devices. To develop new products for our customers, we draw upon the vast knowledge base of circuits that have been shown to perform reliably and accurately on numerous products. We have experience with both analog and digital circuit design and use a variety of design and analysis tools to capture and evaluate circuit designs.

Our electrical engineering expertise includes:

Electronic Circuit Design

Electronic circuits and connecting cables are the central nervous system of most medical device systems. In particular, microprocessor circuits provide the intelligence for controlling functions such as liquid-level sensing, temperature regulation, reagent dispensing, and motor movements. We leverage our years of experience with a broad range of microprocessor-based instrumentation to design electronic circuitry that meets project requirements with high efficiency and low cost.

We have expertise in a number of core technologies, such as liquid level sensing, stepper motor controllers, and thermal control. Having worked with a number of proven circuit designs, we create medical devices and instrumentation with high reliability. Design of cost-effective microstepping motor driver boards, controlling up to 28 motors from a single microcontroller, is a special area of expertise.

Our electrical engineering group is expert at both analog and digital circuit design. We’ve engineered circuits, ranging from high-power motor control circuits to low-power amplifier circuits used to sense the smallest biological signals. Also, we are adept at designing user interfaces, such as touchscreen displays and custom keypads.

At KMC Systems, each electronic component is selected with quality, consistency, and availability. We use quality parts, which allow medical instruments to function reliably for many years over an extended temperature range.

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Test System Design and Development

For medical devices and instrumentation, test systems are essential for product acceptance testing, calibration and alignment, assembly testing, and troubleshooting. At KMC Systems, we design test systems concurrently with product development to optimize product quality and speed the time-to-market.

Specializing in computerized special-purpose test sets for mixed-technology assemblies and modules, we have extensive experience in the development of test systems for medical devices. This allows us to quickly identify the medical device parameters that will have a significant effect on system performance, whether dispensing accuracy and precision or robotic arm speed. We then develop systems to effectively and efficiently test these critical parameters. Our capabilities include the development of systems for testing motion control, fluids handling, sensitive optical detection, imaging, pressure, and thermal control.

We also used advanced medical device software tools that enable us to rapidly develop testing systems. This capability permits testing to begin earlier in the product development process for more stringent quality assurance and a smoother transition to manufacturing.

We have a well defined and documented process for developing test systems, which provide a documentation package compliant with FDA and ISO standards. Test system requirements are defined and the test system is formally validated.

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Safety and EMC/EMI Certifications

KMC engineers understand the industry requirements for medical product certification and the schedule implications of a failed agency certification test. Design solutions are tested during the development process, so when the product goes to the testing agency for certification testing, it will pass the first time.

Before your medical device can be sold, it must demonstrate compliance with electrical safety and EMC/EMI standards. This mandatory process ensure that your medical device poses no fire, shock, or overall safety hazards to anyone coming into contact with your product. EMC testing is conducted to assure that your product's emissions will not affect the normal operation of other products in the same environment, and that emissions from other products will not affect normal product operation. KMC engineers have broad experience with methods and techniques for developing cost-effective compliant designs.

Market access in today’s global environment requires an integrated compliance solution. KMC works with the independent, OSHA-recognized Nationally Recognized Testing Laboratory (NRTL) throughout the product development process to meet you regulatory needs. Once your product has been found to be in compliance with the applicable safety requirements, the appropriate mark will be applied to your product. Our engineers are knowledgeable of the standards governing the compliance with the Medical Device Directive (MDD) and In-Vitro Device Directive (IVDD). KMC has acquired certification marks, on the behalf of our customers, for North America, the European Union, the far-east, and many other global markets.

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