Why Automation inMedical Device V&V?

Webinar Recap: Automation in Verification & Validation (V&V)

Software and system complexity in medical devices continues to increase, and with it, the pressure to improve speed, quality, and compliance in Verification & Validation (V&V). In our recent webinar, PulseForward explored how automation is reshaping V&V processes and where organizations can gain efficiency without compromising regulatory expectations.

The discussion focused on practical applications of automation across test planning, test execution, traceability, and defect management, while highlighting how teams can maintain alignment with FDA, ISO 13485, IEC 62304, and risk management expectations.

Key topics included:

• Where automation fits within the V&V lifecycle

• The difference between manual, semi-automated, and fully automated testing

• How to improve repeatability and reduce human error

• Building traceability between requirements, risks, and verification evidence

• Integrating automation into software and system-level testing

• Common pitfalls when scaling automated test frameworks

One of the core themes of the webinar was that automation is not simply about speed. It is about creating more reliable engineering work products, improving coverage, and strengthening regulatory evidence throughout the product lifecycle.

As medical device software grows more complex, organizations that strategically implement automation in V&V will be better positioned to improve quality, accelerate releases, and maintain compliance.

At PulseForward, we help teams build scalable V&V frameworks, strengthen design controls, and integrate automation into regulated product development environments.

View the Webinar here: Automation Webinar