Medical Device Development
Your engineering partner for bringing medical device products to market
Sterling Medical Devices offers the industry knowledge and expertise in engineering medical devices that you expect in a partner to help bring your medical device software, hardware, and mobile medical device apps to market. Our full-time team of skilled engineers have extensive experience in the medical device industry and their focus is on ensuring the job is done right the first time.
Since 1998, Sterling Medical Devices has focused on helping clients – from startups to leading medical device organizations – to develop innovative medical device products. And we help clients navigate the FDA and CE submission process.
From design, to engineering and integration, to testing, and beyond, we’ll work with you at any phase of the process. Whether you are seeking to develop a new medical device product or improve an existing device, Sterling Medical Devices can help.
Services for your medical device development needs
• Full life cycle approach to medical device engineering, design, and development for most medical device types, including implanted devices
• Medical Device integration and testing
• External support and monitoring devices
• Work on 510K, PMA, and CE Class I, II, and III devices resulting in successful submissions
• Get products to market while minimizing development time and cost
• Utilize state-of-the-art tools and electronic test equipment
• Perform independent verification/validation of medical systems to support your submissions
• Proven track record of FDA and CE Mark approvals for our clients
Helping you meet regulatory goals
Sterling Medical Devices is ISO13485 registered and compliant with standards such as IEC 62304, ISO 14971, and IEC 60601. So as you prepare to navigate the regulatory process, you can have complete confidence in our ability to help you meet quality, control, and compliance goals at the highest levels.
Delivering what you need, when you need it
Our team of medical device engineers start by fully understanding your development needs. By giving proper attention to clinical, regulatory, and engineering constraints, we make sure that the overall system and subsystem requirements are met.
Keeping you informed every step of the way
We welcome your recommendations and input throughout the medical device development process. We always operate with transparency and keep you involved in the review and approval of all phases to make sure that what we develop is what you expect. We provide weekly project schedule updates, and employ the critical chain model with a built-in safety buffer for accurate timeline estimates. And if new features need to be implemented, you’ll see exactly how, and if, the timeline will be affected.
Maximizing efficiency through experience
Our engineering methodologies are optimized to keep expenses low and development times down. We know how to minimize the total duration of the project to maximize your return on investment – all while keeping your bottom-line costs at a minimum. Plus, our reverse engineering service allows our clients to quickly create prototypes and utilize prior work to generate all the necessary documentation required for regulatory approval – all without compromising quality.
Learn more about our medical device development services. Call 201.227.7569 ext.2
VIDEO: Risk management that saves time, saves money
If you’re looking to market your medical device then you need to pay attention to ISO 14971 and IEC 62304. Otherwise, you may wind up having to redesign your whole product, resulting in slower time to market and unforeseen increased costs.
ISO 14971 and IEC 62304 are very detailed, involved medical device risk management standards essential to your risk management process. In the U.S., the FDA expects to see a process compliant with ISO 14971 and IEC 62304 is recognized as complying with FDA guidance that an industry recognized software development lifecycle (SDLC) be followed. And in Europe, IEC 62304 is viewed as “state of the art” and prescribes that you must do your risk management according to the requirements of the ISO 14971 standard. In other words, these two standards are tightly linked together and understanding them is necessary for a rigorous risk management process and regulatory compliance.
Every process of the medical device lifecycle requires careful attention to risk: from software engineering planning to implementation to testing to final reporting. At Sterling Medical Devices, we’ve guided our partners through the risk management process on over 500 projects, helping to give them an advantage in their respective marketplaces.