Regulatory & Medical Device Industries

 Regulatory Medical Device

Regulatory Compliant Software Testing

The US government is becoming increasingly strict about software testing within various industries such as healthcare and finance. This is because bugs within these systems can have a hugely detrimental financial or medical impact on the quality of life of many Americans.

Independent Verification and Validation of these systems ensures your product meets not only your own acceptance criteria, but also meets the requirements of any governing body such as the FDA. Doing so in a way that protects your company’s Intellectual Property is especially important in these fields, and our convenient U.S. based offices make sure that your IP is not only secure, but in the hands of people working alongside your team ensuring the best product possible.

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How You Can Benefit


IP Protection

Our medical device clients like working with us because we are an American based company with offices located throughout the United States. This allows our clients the security of knowing their Intellectual Property and expensive medical devices can remain local and secure. U.S. based offices also mean that all of our staff work in the same general time zone as you to make sure collaboration and communication remain easy and efficient.

Independent

An IV&V provider is a knowledgeable and engaged advocate working on your behalf throughout the development process, independent of any business considerations or internal politics of development organizations.

  • Technical independence ensures that IV&V providers practice accepted Quality Assurance methodologies.

  • Managerial independence allows IV&V providers to offer objective and timely reporting directly to your organization.

  • Financial independence, in the form of a separate budget, ensures that IV&V effectiveness is not compromised

Verification

Verifying that each step in the development process is complete and on track.

  • Ensure each phase of development meets acceptance criteria for the next phase.

  • Adhere to testing methodologies, provide timely test, status, and bug metric reports.

  • Check that all critical problems are resolved before the final release.

Validation

Validating that the final product satisfies functional and other requirements as documented in original software design specifications.

  • Advocate usability for ultimate end-users.

  • Track enhancements not just bug fixes.

  • Ensure that the system performs to expectation under all operating conditions.

 
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 - Software Engineering Manager, Spirosure, Inc.
 
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The Shasta QA Process

NEEDS ANALYSIS

Shasta QA meets with you to better understand your goals and challenges then develops a team alliance that transforms traditional outsourcing from compulsory need to a valuable competitive advantage.

PROJECT PLANNING

Shasta QA works with you to develop a unique roadmap that includes planning and scheduling efforts, and a well-developed strategy to ensure adequate test coverage to drive your project to completion.


PROJECT EXECUTION

Shasta QA conducts proper reporting practices that monitor and track the progress of your project so you can make real-time decisions regarding the application development.


PROJECT MASTERY

Shasta QA uses a success formula that includes risk reduction methodologies, process adoption and bug modeling to improve and master overall project processes to strengthen your bottom line.