Medical Device Software Testing Services: Outsource Your QA

Timothy Joseph
Timothy Joseph | June 4, 2019
Medical Device Software Testing Services: Outsource Your QA

Digital technology faces its sternest test when it is applied to our health. The benefits of speed, accuracy and automation are balanced against the responsibilities of consistency, reliability and mobility.

Those who work in the medical software domain are charged with walking the line between innovation and regulation. Every potential advance in medical device sophistication faces a gauntlet of regulations before it ever gets tested within the realities of the commercial market. It is a double challenge that requires greater attention to detail than just about any other development field.

Fortunately, there is help at hand.

Outsourcing the responsibilities of medical device software testing helps to alleviate this particular burden on those with the vision to keep us healthier. External QA experts have the qualifications, organizational protocols and resources to make sure every potentially life-saving device gets to see the inside of a hospital.

What Is At Stake for Developers in the Medical Domain?

Healthcare software developers put their reputation on the line with each medical device innovation.

  • They must create products that strike a balance between cost and value to the customer.
  • They must guarantee the security of private and confidential patient data during testing and development and once it goes to market.
  • They must ensure the safety of all patients and medical professionals who interact with the product once it is released.
  • They must meet all the qualifying regulations of agencies such as HIPAA and FDA.

And, they must check all these boxes while delivering to release and resource restrictions.

If ever a group needed expert external assistance, it is the medical software developers.

The Advantages of Outsourced Medical Device Software Testing

External QA providers are domain experts. The competitive nature of the outsourcing industry has led to the creation of industry-specific QA teams immersed in their field. Offshore locations such as India have invested heavily in engineering, resulting in the annual influx of 1.5 million graduates from more than 2,000 specialized colleges.

Searching for an edge when serving large markets, such as the U.S., has left these teams with unrivaled expertise in the medical field, especially when it comes to audit responsibilities and HIPAA compliance.

As a result, they offer QA advantages that outweigh the traditional resource-cost incentives.

The right QA partner can provide:

  • Thorough, audit-proof documentation of every step of the testing phase
  • HIPAA-compliant data sanitization and encryption
  • Strict user access control
  • Physical and logical protection standards
  • FDA-compliant documentation for each test element
  • Validate secure transmission of PHI (Protected Health Information)-or ePHI (electronic PHI)-which occurs during health-related financial transactions

It takes a lot of resources to coordinate and implement these standards within a functioning test regime. Outsourcing QA takes that burden away from the development team. It is all done in addition to the usual task of assessing risk before release.

This regulatory responsibility is only part of the outsourced QA package. Partnered healthcare developers also gain practical product advantages that improve quality, resource savings and ROI.

Developing Safer Products More Efficiently

Healthcare applications may face greater regulation and audit responsibilities than products produced in other domains do, but they remain commercial products regardless. As such, the QA expert must deliver on both fronts-innovation and regulation.

For a start, producing medical device software will require integration testing. Your QA partner can guide you in choosing the option that will best suit your needs. On top of that, there are important security concerns around keeping data secure within the device itself.

A quality QA service with domain expertise can navigate these decisions and processes. This kind of assistance leads to testing efficiencies that improve product quality and save time. To ensure your product meets the security and stability requirements, for instance, your QA partner should have a working knowledge of the various compliances, security guidelines, tools and technologies currently available.

In addition to these resource advantages, outsourcing medical device software testing can save you money. Teaming up with an offshore or nearshore partner-or a mix of both offshore and nearshore to maximize resources and workflow potentials-can save up to 50% of your QA spend.

It is all about leveraging the expertise and resources of your partner to provide better ROI on your product-a valuable asset within a healthcare field that is constantly waging a cost versus benefit battle.

Along the way, you are engaging expert testing that helps build safer products that deliver significant health benefits to patients.

Experts in the Medical Device Software Testing Process

Outsourcing medical device software testing helps you better meet the twin challenges of healthcare development. It gives you compliance expertise ready to onboard and scale up production when needed, and it gives you professional QA expertise ready to streamline your resources and schedules toward achieving comprehensive testing quicker.

It is a partnership designed to help shoulder the regulatory burden so nothing stops you from innovating within a life-saving field.

QASource offers a combination of healthcare domain expertise and leading software testing technologies to make sure your product achieves its potential. Our engineers will help you cover all the terminology, conformance, transport and security standards that allow you to make a lasting contribution to the medical field. Contact us today for a free quote, or call +1.925.271.5555 to get started.


This publication is for informational purposes only, and nothing contained in it should be considered legal advice. We expressly disclaim any warranty or responsibility for damages arising out of this information and encourage you to consult with legal counsel regarding your specific needs. We do not undertake any duty to update previously posted materials.