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Software Development Services

Our Software Development Services address all aspects of the software development process. From concept to customer and beyond, Neuma’s software development team is available to partner with clients throughout all phases of the product development lifecycle.

 Figure 1: Customer's Design Processes (GMP)

Software Development Life Cycle (SDLC)

Regardless of industry sector, solid software engineering techniques are a key enabler for delivery of high quality products, but they’re especially important for medical devices. In the United States, the Food and Drug Administration requires medical device manufacturers to comply with federal regulations governing product development. The software components of any medical device must comply with these regulations.

Software Requirements

Neuma’s software development philosophy begins with a robust requirements and specification framework. Our focus on early requirements definition is rooted in our background as medical device product development experts: we understand the importance of clear requirements throughout the product development life cycle – and we have seen the cost and complexity issues arising from failure to develop a clear requirements specification early in the SDLC. Our team partners with clients to:

  • Understand and derive software requirements from product, system and hardware requirements

  • Ensure that regulatory requirements required to meet FDA and CE are treated as design inputs early in the product development process

  • Understand the relationship between Essential Performance Requirements and software deliverables

  • Provide Risk Analysis and Risk Management Planning associated with software tasks

  • Establish a traceability framework early in the design process that supports later phases in the software development lifecycle

Software Design and Implementation

Our team can deliver software architectures to suit your project’s specific needs, coded to execute in a variety of hardware platforms. Some of our target platforms and environments include:

  • Embedded applications running on a range of embedded platforms from the 8-bit STM8 series through 32-bit environments such as the LPC2148 (ARM7-based) devices

  • Varied architectures from bare metal programming, Real Time Operating Systems (RTOS) environments such as TNKernel and larger footprint operating systems (Linux, Windows)

  • Onboard storage devices for data logging (EEPROM/SD)

  • Low power embedded systems reliant on batteries

  • Lower level programming languages such as C or assembler through higher level scripting languages like Perl, Python, PHP

  • GUI development using frameworks such as GTK2+

  • Communication technologies and buses such as RS-232, SPI, I2C and IP

  • Custom digital and analog device control

  • Data management tools (relational databases, flat file systems, N-cube data models)

Software Verification and Validation (V&V)

Neuma assists clients with software V&V activities from software unit testing (verification) and integration testing through high level software requirements validation. For embedded device software V&V, Neuma provides analytical and technical solutions to ensure that product software meets requirements and design specifications:

  • Developing software unit and integration test plans

  • Conducting hardware/software integration testing

  • Developing custom test fixturing to support complex integration and software performance testing

  • Testing from the system level down to the hardware level using in-house test equipment

  • Providing test reports to support regulatory submissions