Medical Device Electromechanical Design
Sterling Medical Devices – A trusted partner for your electromechanical design
Hardware and Electromechanical design are often required for many of our clients’ medical device projects. We have designed for a wide range of electromechanical medical devices, from table top sized equipment to implantable devices, always designing with a focus on performance, reliability, cost, manufacturing, and regulatory compliance. Sterling Medical Devices can help you address your electromechanical design challenges at any phase of the design process, whether your product requires a conventional design or an advanced integrated architecture.
Our experts offer wide-ranging experience in medical device electromechanical design.
As a part of that focus we recognize that different approaches may be necessary for different types of electromechanical design projects. For example, it may make more sense to use an off-the-shelf / open source type OS with a Single Board Computer and then pair it with a smartphone app; where in other cases a customized approach controlled down to the microcontroller level and connected wirelessly to a PC / tablet running custom software may better deliver the desired system level control (with the proper degree of risk mitigation) for that particular set of product needs.
Medical device electromechanical design expertise
Sterling Medical Devices engineers have wide-ranging electromechanical design experiences, including designing and working in manufacturing environments. Our team is highly innovative, offers decades of medical industry experience, and brings with them a large body of technical knowledge including engineering applications, manufacturing transfers, manufacturing pilot-runs, troubleshooting experience, and reverse engineering capabilities.
Our experience in designing complex electromechanical systems with embedded firmware includes:
- Analog and Digital circuit design
- Complex analog filtering
- Signal conditioning and impedance matching
- Analog to Digital and Digital to Analog converters
- Switching AC and DC power supply design / characterization
- Bluetooth (classic and low energy)
- High and low frequency RF communication (custom NFC solutions, MedRadio, RFID, etc.)
- Wireless battery charging
- 8 bit up to ARM/Blackfin microcontrollers
- OTS Sensor integration
- Custom flexible heaters and temperature control
- Precision Motion Control using DC stepper motors and encoder feedback
- Multi-layer Printed Circuit Board (PCB) design
- Circuit and battery analysis / characterizations over varying system and environmental inputs
- Resolving electrical noise and circuit instability
- Ability to mediate failure problems / root cause analysis
- System tear down and reverse engineering
- Mitigation of EMC and ESD failures for IEC60601 / IEC61010 / IEC60950 standards testing
Medical Device Electromechanical Design- Risk based approach
Whether using a higher-level RTOS or controlling the software functionality through lower-level programming, we employ a risk-based approach to medical electromechanical design. We leverage our extensive experience in designing medical electronics to help you identify potential risks in your project and identify the right architecture approach for your products. And we have experience in mitigating for ESD, high-frequency, and low-noise.
Electromechanical Medical Device design- under Sterling’s Quality System
Ensuring your medical device electromechanical design is safe and effective requires a high level of expertise and razor-sharp focus on quality. Our team of engineers and project managers work closely with you to select or design the right medical electromechanical technology components to make your medical device products more reliable, efficient, and ready for FDA and CE Mark review. Working with Sterling also allows you to design your device under Sterling’s quality system. Sterling is ISO 13485 registered and its quality systems and practices are compliant with standards IEC 62304, ISO 14971, 93/42/EEC, and IEC 60601. Therefore Sterling’s ISO certifications allow its start-up and established medical device customers to streamline their auditing process and speed up regulatory approvals.
Since our founding in 1998, Sterling Medical Devices has demonstrated expertise in delivering medical devices and related services that are aligned with customer and regulatory requirements. We help customers, ranging from startups to Fortune 500 corporations, in all facets of Class I, II, and III electronics medical device design by minimizing risks, overcoming time and budget obstacles, and maximizing chances of a successful FDA & EU approval process by doing things right the first time.
Our experienced medical device design electrical engineers, software developers, mechanical designers, system specialists, and project managers can help drive your medical electromechanical design process by:
- Adding value to your medical device project at any phase of the medical device hardware design process; from design to engineering to testing and more.
- Ensuring that your 510K, PMA, and CE Class I, II, and III devices result in successful submissions.
- Benefiting from our established and registered quality system.
Learn more about our medical electronics design services. Call 201.227.7569 ext.2
Free Project Analysis
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