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Wherever you are in your product development lifecycle,
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Medical Device Software & System Development

Achieve faster market entry and regulatory compliance with Sterling’s expert medical device software & system development.

Ensure FDA-Compliance in Your Medical Device Software

Streamline your device-to-market process in a way that ensures your software is FDA-ready.

Why choose Sterling for medical software & system development?

  • Navigate FDA and CE Marking regulations effortlessly with our expert regulatory guidance.
  • Minimize project duration and maximize ROI through our optimized development methodologies.
  • Ensure your medical device software meets ISO 13485 and IEC 62304 standards.
  • Receive weekly project updates and transparent timeline estimates from your program manager.
  • Leverage our 20+ years of specialized knowledge in medical device development, including software development.

Request a Quote for Our Medical Software Development Services

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ISO 13485 Certification – ISO 13485 is an internationally recognized quality standard for the medical device design, development, production, and the sale of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements. In addition to approving Sterling’s quality systems and practices, ISO certification allows our customers to streamline their auditing process.

Medical Device Design and Development Industry Affiliations

As a forerunner in custom software solutions for the medical device design and development industry, Sterling Medical Devices is affiliated with the leading industry associations.
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Featured Design & Development Services

Software Development

Streamline your medical device software development process with our experienced experts at the lead.

Regulatory Compliance

Ensure compliance with both US and European standards by choosing a partner who knows FDA & CE Marking.

Quality Assurance

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.

Telehealth Solutions

Adapt to the growing telehealth market by integrating our remote healthcare delivery solutions.

Risk Management

Minimize software design risks and prevent costly recalls with our risk management approach.

Cloud Integration

Ensure reliable, cloud-compatible devices by utilizing our testing and regulatory processes.

Firmware Design

Optimize your device's real-time operating system interface with our expert firmware design services.

Mobile App Development

Design reliable, secure medical software for iPads, iPhones, and Android devices.

Medical Device Software

Cybersecurity in Medical Device Software

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.

Systems Development

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.

Medical Device Software
Medical Software Development Services

Value-Based Healthcare Alignment

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.

Accelerate Your Time-to-Market Without Cutting Corners

Trust Sterling’s streamlined medical software development process to ensure a smooth path to approval.

Frequently Asked Questions

What Is Medical Device Software?

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.

What Is The Difference Between SiMD & SaMD?

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.

What Is The Difference Between Class I, II, and III Medical Devices?

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.

How Does The FDA Approve Medical Device Software?

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.

What Is The Most Commonly Used Medical Device Software?

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.

Your Best Choice for FDA-Compliant Medical Software

Secure your medical device software’s FDA compliance and simplify your journey to market.

Why contact Sterling Medical Devices?

  • Leverage our years of expertise tailored to your unique needs
  • Utilize our deep knowledge of global regulatory requirements, including EU MDR.
  • Take advantage of our focus on real-time data collection and analysis.
  • Trust our ISO 13485 certification to guarantee robust quality assurance in your medical software.
  • Align your medical software cybersecurity with FDA’s latest guidelines from 2023 onwards.

Reach Out Today

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July 29, 2015

White Paper – 4 Factors to Consider When Developing Your mHealth Product

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5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

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 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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