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Software Engineering
Our software engineering team emphasizes developing software to meet user needs while remaining compliant with FDA and ISO to deliver solutions for operation in regulated environments.
Learn more about our Capabilities
We know that software receives extra scrutiny in the regulated environment and therefore we place significant importance on the software development lifecycle following ISO 62304, HIPAA and the 2022 draft guidance for Cybersecurity in Medical Devices. We have helped numerous companies bring their development cycle in sync with expectations of regulated bodies (FDA, CE) and standards, allowing for a seamless integration of work products into the technical file for regulatory submission.
Areas of Expertise:
- Requirements and Risk Management
- Architecture
- OS – Windows, Linux, RTOS, iOS, Android, uCOSH, OSx
- Real-time Embedded designs
- Signal Processing
- Drivers
- Battery Management
- Image processing
- Communication and Connectivity (e.g. HL7, cloud API)
- Networking
- Applications
- UI/Ux
- mobile
- cloud/data
- database
- data analytics
- EHR
- Cybersecurity – Authentication, Encryption following the 2022 draft guidance for Cybersecurity in Medical Devices
- Unit testing
- Legacy system porting and reverse engineering
- Maintenance
- GIT, code management over 10M+ lines, release management, branching, development strategies across large and geographically diverse teams
- IS
- 62304 and FDA Design Control
- Constantly mindful of interfaces and cross-disciplinary considerations (HFE/ID, electrical, mechanical, manufacturing testing, etc.)
- Languages: C, C++, C#, Objective C, Java, MATLAB, Maple, FORTRAN, Ruby, Perl, Python, LabVIEW, Agilent VEE
- Development Environment: Visual Studio, .NET, Embedded
- Processors: Intel, TI, ARM, ARK
- Tools: JIRA, Subversion, Visual Studio, Compilers, Wireshark
