Standards

IEC 62304

IS 13485:2016

AAMI TIR 45

HIPAA

Development Process

SOLID

Algorithms

Prototyping

Security

Applications

Full stack

RTOS and bare metal

Mobile

Desktop

Best Practices

Agile/Scrum

Code standards

Continuous integration

Test-driven development

Software Designed to Standards

We use IEC 62304-compliant software development lifecycle (SDLC) processes and our certified quality management system (QMS) to provide custom software development across a variety of regulated and non-regulated industries, including medical devices and diagnostic instruments. Our QMS is certified to ISO 13485:2016 standards and our processes satisfy FDA and HIPAA requirements necessary for Class I, II, and III medical devices.

Development Process

NOVO’s software development team makes security a top priority and integrates it into our development process. Our engineers follow the SOLID design principles throughout the SDLC for ease of development, extension, and maintenance. During our IEC 62304-compliant SDLC process, we determine whether the medical device or application has specific core algorithm requirements; if so, we work closely with the client during algorithm design, testing the implementation of those algorithms via prototypes and providing appropriate sensitivity and robustness metrics for verification purposes.

Applications

We support our clients’ software development needs on a wide a variety of platforms: Windows and Linux desktop, iOS and Android mobile, and embedded applications for real-time operating systems (RTOSs) and bare metal. We provide custom full-stack software development services for applications and Class I, II, and III medical devices. Our software development teams have experience taking projects from initial concept to validation-ready applications. We work with our clients’ subject matter experts (SMEs) after a proof-of-concept has been developed and continue through the remaining phases of the SDLC.

Best Practices

The development teams at NOVO Engineering follow the Agile/Scrum methodology, including ceremonies, artifacts, and adherence to roles, to improve speed to market and responsiveness to our clients’ needs. We utilize a test-driven development approach, including unit and integration tests, and we implement continuous integration to ensure tests are always run after code is merged. We have a single coding standard that facilitates reading and sharing among developers.