Streamline your device-to-market process in a way that ensures your software is FDA-ready.
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Wherever you are in your product development lifecycle,
Sterling can help.
P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com
Why choose Sterling for medical software & system development?
Streamline your medical device software development process with our experienced experts at the lead.
Ensure compliance with both US and European standards by choosing a partner who knows FDA & CE Marking.
Achieve ISO 13485 certification for your device software with our robust quality management systems.
Safeguard patient data and device functionality with device developers who prioritize cybersecurity.
Adapt to the growing telehealth market by integrating our remote healthcare delivery solutions.
Minimize software design risks and prevent costly recalls with our risk management approach.
Ensure reliable, cloud-compatible devices by utilizing our testing and regulatory processes.
Optimize your device's real-time operating system interface with our expert firmware design services.
Design reliable, secure medical software for iPads, iPhones, and Android devices.
The increasing connectivity of medical devices exposes them to cyber threats, putting both patient data and device functionality at risk.
Sterling aligns its cybersecurity measures with the FDA’s most recent guidelines.
Sterling is also proud to provide the gold standard of medical device cybersecurity documentation. Let us help navigate you through critical deliverables to ensure you are successful in gaining device approval.
Design with cybersecurity in mind from the start of your project. Avoid costly and time-consuming backtracking and meet the latest FDA cybersecurity standards.
Creating a software system that works well with medical devices is a tough job. If it’s not done right, you could face delays, extra costs, and trouble getting your device approved for the market.
Sterling’s skilled U.S.-based team is well-versed on how to develop systems that span a wide range of therapeutic areas and diverse technologies.
We’ll also always keep you informed during development with regular updates and clear timelines.
We use proven methods to keep your project on schedule and within budget. Our quality system meets high industry standards, making the approval process much easier for you.
The move to value-based healthcare is changing the way medical services get paid for and evaluated. If your medical device software doesn’t fit this model, you could face lower sales and payment issues.
Sterling helps you make sure your medical device software fits well with value-based healthcare. We focus on creating devices that both improve patient health and save money. This approach sets your product up for success in the modern healthcare world.
We follow key principles from the Value-Based Healthcare Project to guide our work. This ensures your product not only meets but goes beyond current healthcare standards.
Trust Sterling’s streamlined medical software development process to ensure a smooth path to approval.
Medical device software is a component, part, or accessory of a medical device that controls its operations or analyzes data.
This software can be embedded in the device itself or operate separately on a computer or mobile device.
It can be helpful for diagnosing, monitoring, and treating various medical conditions.
SiMD (Software-in-a-Medical-Device) is software that is embedded in a medical device and functions as a component of that device.
On the other hand, SaMD (Software-as-a-Medical Device) is standalone software that performs medical functions without being part of any hardware.
While SiMD relies on a specific device to operate, SaMD can run on general computing platforms and is often more flexible in its applications.
Class I, II, and III medical devices vary in risk levels and regulatory requirements.
Class I devices are low-risk and need basic controls such as labeling. Examples include bandages and tongue depressors.
Class II devices have moderate risk and require additional controls like performance standards, infusion pumps are an example.
Class III devices are high-risk and need pre-market approval. These are often life-supporting devices like pacemakers.
The FDA approves medical device software through a rigorous process that evaluates its safety and effectiveness.
Initially, developers submit a pre-market notification or a pre-market approval application, depending on the device's risk classification.
The FDA reviews the software's design, clinical data, and quality assurance measures.
After successful evaluation, the FDA grants approval, allowing the software to enter the market.
Almost every medical device now runs on software to enhance precision, data analysis, and ease of use. Software allows for real-time monitoring and quick adjustments, which are crucial in medical settings.
Common examples of medical devices that rely on software include infusion pumps, ventilators, and diagnostic imaging systems like MRI and CT scanners.
Why contact Sterling Medical Devices?
July 29, 2015
February 18, 2021
September 8, 2020