Device Software V&V

BPA verification and validation services

BPA provides a full range of services related to the verification and validation of software in a medical device, or that is a medical device itself. The following are examples of such services:

• Performing a device and/or software hazard analysis and identifying the implications of the hazard for software design and verification and validation.
• Establishing quality assurance processes for device software.
• Performing medical device software testing (verification), including a test plan, traceability matrices, preparing and executing software tests and writing reports.
• Designing validation studies and support in the execution of the studies.
• Preparing software documentation for submission to the FDA as part of the product approval submission. Such documentation will follow FDA guidance documents on pre-market submissions.

BPA product development services

BPA's assistance with product development can include:

• Establishing a design control process compliant with the FDA Quality System Regulations as well as ISO 13485.
• Developing a software lifecycle that is in compliance with FDA guidance, including establishing requirements, designing, developing, testing, and supporting the software.
• Creating a product development strategy and plan. Establishing goals and milestones and getting agreement from key members of the organization.
• Managing and/or supporting the complete product and software development process for a medical device.

BPA provides experience in medical device design, software engineering, and engineering management. We have experience with real time systems, embedded systems, workstations, Windows applications, and user interfaces.

Contact Us
Call Tim Stein at 408-366-0848