Essential Elements of Medical Device Software Architecture
A solid software architecture acts as the foundation upon which safe, effective, and compliant medical devices can be built, particularly when integrating advanced technologies like AI and cloud computing.
Here are some of the ways we’ve helped Medtech firms like yours with the architecture phase of their new product development:
Requirements Analysis
System Design & Modeling
Technology Selection
Rapid Prototyping
Cybersecurity Strategy
Performance Optimization
Documentation & Traceability
Regulatory Compliance
The SEI Certified Software Architect assigned to your project will define a framework that works best for your product. We’ll assess and help negotiate trade-offs between functional requirements and non-functional aspects such as performance, modifiability, security, and safety.
The architecture we create will account for both short- and long-term goals to create a system that is efficient and sustainable over the long haul. Via periodic design reviews with your team, we’ll continuously evaluate and refine the software architecture.
Using the latest tools and techniques appropriate for the complexity of your product, we’ll document the architecture in an easily accessible form to facilitate communication with developers and other stakeholders. The software documentation can follow our architecture templates, based on IEEE standards, or can use your software templates and process.
By carefully crafting an effective medical device software architecture and design, risks can be identified and mitigated early in the development process when the cost of change is low.