Medical Device Electromechanical Hardware Development

Tailoring a Unique Development Process for Each of Our Client’s Medical Devices

We recognize that distinct approaches are necessary for different types of projects and we help you every step of the way to determine the best method for your project. We can help you address your electronics challenges at any phase of the process, from conventional design to an advanced integrated architecture. We help customers, ranging from startups to Fortune 500 corporations, in all facets of Class I, II, and III electromechanical medical device development by minimizing risks, overcoming time and budget obstacles, and maximizing chances of a successful FDA & EU approval. W

Ensuring a Proper Quality System for Your Electromechanical Medical Device Development Process

Working with Sterling allows you to develop your electromechanical medical devices under our 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 start-up and established medical device customers to streamline their auditing process and speed up regulatory approvals.

Leveraging Our Experience to Develop the Best Medical Device for Our Clients While Minimizing Cost and Time

Our team has decades of medical industry experience in engineering applications, manufacturing transfers, manufacturing pilot-runs, troubleshooting, reverse engineering, and analyzing and designing electrical circuits and systems.

Our experience in developing complex systems for electromechanical medical devices 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 a varying system and environmental inputs
• Electrical noise and circuit instability resolutions
• 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

Risk-Based Medical Device Electronics Development

Whether using a higher-level RTOS or controlling the software functionality through lower-level programming, we employ a risk-based approach to the development of electromechanical medical devices. We leverage our extensive experience 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.

Safe and Effective Medical Device Hardware Designs for Innovative Products

Ensuring your medical device’s 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 works closely with you to select the right medical electronics design technology to make your products more reliable, efficient, and ready for FDA and CE mark review.

Why Sterling?

Why choose us as your medical electronics design and development partner? Our company has been providing medical device design and development services for decades, adhering to the highest and most rigorous standards for medical devices design and development in the industry.

Our experienced medical device development electrical engineers, software developers, mechanical designers, system specialists, and project managers can help drive your medical electronics design and development process by:

• Adding value to your project at any phase of the medical device hardware development process
• 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.

Sterling Medical Devices offers proven, end-to-end medical device development and design experience to help you at any stage of your medical device project. It’s never too late to get us involved. Let us show you how we can add immediate value to the development of your electromechanical medical devices.