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Wherever you are in your product development lifecycle,
Sterling can help.

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Developing safe and effective medical device software.

Medical Device Programming

Medical device software development is an ever-evolving field within the medical device industry, and it is growing increasingly complex in design and functionality. This constant growth matches the growing need for enhanced patient care and therapies. Now more than ever before, you need a trusted partner who can guide you through each and every step of your medical device software development process.

  • Full lifecycle development
  • Software verification and validation testing
  • Design History File (DHF) Remediation
  • Expert testimony
  • Independent medical systems verification/validation to support you submissions

Sterling Medical Devices is well equipped to step in at any stage within your development lifecycle to help you develop a safe, effective, and FDA/IEC 62304 compliant medical device product. Here at Sterling, we will work closely with you and your team to understand every aspect of your design, development, and testing needs to help ensure a quality Class I, II, and III medical device product.

A trusted partner like Sterling Medical Devices can help you address your software design challenges and help you streamline the process of having your medical device product reviewed by the FDA. Our team works with you to understand the intended use of your medical device software and all of the requirements that your software must meet in order to be considered a safe, secure, and compliant medical device product.

 
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About Sterling Medical Devices 

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

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Resources

medical device regulation compliance

October 22, 2021

Common Medical Device Regulatory Compliance Roadblocks

The medical device industry is heavily regulated by the FDA, specifically, the Center for Devices and Radiological Health. Unfortunately, while device manufacturers are required to establish and...
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February 18, 2021

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Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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September 26, 2022

Sterling Medical Devices Creates Controller to Power Puzzle Medical Devices Inc’s. Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

Overview Puzzle Medical Devices Inc., is a leading medical device company specializing in the development of a minimally invasive multi-pump mechanical circulatory support (MCS) designed to reduce...
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