Medical Device Software 

Customized Medical Device Software Development Solutions

Promenade Software, Inc. specializes in custom medical device software development for safety-critical medical device applications. We develop firmware and device applications, mobile medical applications Mobile Applications and Cloud Applications. Our experience in medical device software development gives us the ability to complete projects as quickly and efficiently. Our team is comprised of top level experts in FDA medical device software development.

Medical Device Software Experts

Promenade Software has a staff full of experts that specialize in integrated device software development, mobile apps, and cloud-based applications. Each interface requires the capability to balance user-friendly features with a highly complex design system. Our Parlay eco-system has teh codebases and frameworks that seamlessly connected all system components. This creates a simplistic approach to a multifaceted software structure. The software of these complex systems must support the expanded infrastructure needed for them. It requires research, testing, manufacturing, data collection, and field service software to cohesively create a finished product. Promenade Software provides this complete eco-system for our clients. Our multi-platform applications make your medical data accessible with each device you use. From x-rays, MRIs, or EKGs and blood pressure monitors, we focus on how to simplify your workflow so that you may best serve your patients. Our medical device software development is seen in:

  • Dermatology Devices
  • Cardiovascular medical devices for data analytics or monitoring
  • Disease management
  • Lab management
  • Diagnostic instruments
  • Doctor to Patient engagement
  • Respiratory technology
  • Mobile monitoring systems for patients - heart rate, blood pressure, skin temperature, posture, arrhythmias, and falls

Whether for therapy or diagnostics, custom device software development has blossomed into a far more integrated system. From firmware to full operating systems such as Linux and Windows, mobile devices, and cloud-based software, the foundation of technology needs to be secure, simple to use, and FDA compliant. Creating the medical device software requires immense attention to detail and expertise.

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medical device software regulations

Medical Device Software Regulation

The device classification determines the level of federal compliance. The U.S. Food and Drug Administration (FDA) has established 3 different classes for medical devices. They are classified “based on the level of control necessary to assure the safety and effectiveness of the device”. In other words, the device classification determines the rigor of control expected. All parts of the quality systems can be applicable to software. Software components must be under design control per 21 CFR 820.30. IEC 62304 is the accepted standard for both the FDA and CE mark for life cycle processes for software . Promenade Software provides the full software regulatory package with its engineering services.

Medical device software must ensure the safety of the patient and medical staff. Because commercial technology is used, the division of duties must be evaluated carefully to insure that critical functions are not dependent on software of unknown provenance. Our experts can assist in the risk management and design the system for safety.

Off-the-shelf (OTS) software requires an impact on safety analysis. Cybersecurity protections must be applied and documented for networked devices. These activities are all part of Promenade Software Services.

The Promenade Full Solution

Promenade Software  Inc. prides itself on its solution to seamlessly create, and securely interconnect these technologies. From the ground up, we created a system, which supports all aspects of medical devices, and their infrastructure needs. Only the customization that makes your device unique need be created. This reduces your time to market and expense by more than half. It also gives you unprecedented reliability along with enhanced capabilities of research and test.

Contact us for more information how we can help bring your device to market quickly and efficiently.

Contact us
process for quality
16 Technology Drive, Suite 100
Irvine, CA. 92618, U.S.A.
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Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is ISO 13485 and CyberMed • Cloud is SOC2 Type II certified.

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