Regulatory Testing

Regulatory Medical Device

Testing Solutions for Regulated Medical Device Software Validation and Verification

Regulatory Compliant Software QA Testing is critical to the effectiveness, competitiveness, and survival of your organization. Unexpected behavior or critical problems that bring your operations to a standstill are just not an option.

Independent Software Verification and Validation increases the probability that customized software QA testing will achieve:

  • Design requirements

  • Objectives within budget constraints

  • Scheduled delivery dates

When integrated into the software development life cycle, IV&V can detect and identify risk elements throughout the entire software development process. This allows development and quality assurance managers to respond quickly in order to mitigate risks earlier in the product development life cycle, with more effectiveness, and with less impact on cost and schedule.

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What Is Tested

Medical Devices

The industry most affected by regulatory testing compliance is the medical field. Shasta QA specializes in medical device testing across many different fields and houses all equipment onsite at one of their facilities to ensure IP protection.

Data Privacy

Protecting personal data is a key component in any software testing strategy, and especially so in the medical device industry. Shasta QA will help ensure you stay compliant will all regulated requirements regarding data protection.

FDA Compliance

We understand the importance of being properly prepared and compliant when it comes to FDA approval. Shasta QA not only ensures any integrated software will meet FDA requirements, but also be of the highest possible quality.


Depending on the type of medical device in use, the integrated software may have to work well with other applications on the system, or in different environments, and ensuring Interoperability of integrated software using as many variables as possible is essential for a good user experience.

Functional and Usability Testing

We go above and beyond simply verifying that the software meets all requirements by testing all application functionality and usability during our process. This ensures not only the highest quality product, but also a user-friendly experience that will keep your customers coming back.

Automated Regression Testing

Shasta QA can help automate your repetitive regression tests in order to increase speed and efficiency, while at the same minimizing the chance of human error.

It has been close to two years working with Shasta QA and they have been an essential part of our software development operations.

Among all the software QA vendors I have worked with, offshore and remote within the US, in my 20 years of software development experience, Shasta QA is the vendor who provides the most quality output.

I highly recommend working with Shasta QA with confidence.
— Steve Lim - Quality - Software Engineering Manager, Spirosure, Inc.