As medical devices become increasingly complex in functionality, medical device companies are seeking reliable partners for their electromechanical medical devices. At Sterling, we have created systems to guide clients throughout their device’s development process.
Our expert engineers always design electromechanical medical devices with performance, reliability, cost, manufacturing, and regulatory compliance in mind. We offer specialized skills and abilities in the development of electromechanical medical devices, focusing on a product scale from tabletop sized equipment to implantable 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
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.
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:
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.
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 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:
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.
March 29, 2021
September 7, 2022