Software Quality Engineering and Test Support

Software Quality Engineering and Test Support is our Most Requested Solution

Our experienced software test engineers have extensive medical device testing knowledge necessary to hit the ground running. This capability allows our clients to meet their quality goals and delivery dates.

“Lina did a great job for us, leading the testing effort. Kris was great as well – very flexible and responsive to any issues. They’re a great team to work with!”

Don Canal
Senior Management – Clarify Medical
medical device software quality help SaMD

Medical Device Software Quality Engineering Support

  • 3 Options Available
    • Utilize Advantu’s Test Labs
    • Remote Testing Support
    • Onsite Testing Team
  • Improve build turnaround velocity
  • Discover critical defects early
  • Find high severity bugs after software fixes
  • Ramp up quickly with highly experienced professionals
  • R&D and manufacturing documentation exceeds compliance standards
  • Meet realistic project deadlines while enhancing quality and reliability

Software Quality Engineering Process Improvement

  • Establish project needs and resource requirements for maximum effectiveness
  • software testing help SaMD
    Conduct gap analysis to determine state of SQE program and test readiness
  • Enterprise – SaMD – Embedded – Mobile App
  • Match project requirements with resource skill sets and capabilities
  • Perform requirements decomposition for test plan/cases creation and traceability
  • Scope the project and provide estimates for test preparation, execution & defect management activities
  • Collaborate with business/marketing to ensure test team remains in sync with project requirements
  • Prioritize testing activities guided by prioritized risk assessment of the product and/or system under test
  • Ensure timely reporting of all test execution and defect submittal/closure results
  • Work closely with R&D to support anomalies and impacted area testing
  • At successful test completion provide a thorough report detailing requirements coverage and hazard mitigations

Manufacturing Process Validation / Intended Use Validation (IUV) Support

  • 21 CFR Part 820/ISO 13485:2012 – Validation of a Manufacturing and/or Production Process
    • Installation Qualification (IQ)
      • Ensure all manufacturing processes are validated and operations performed by qualified individuals
        • Basis for IQ are the installation drawings and specifications (with the installation requirements)
        • During this phase, equipment maintenance and calibration schedules & procedures are established
        • Equipment should be calibrated before and after process validation to determine whether equipment remained in calibration during the entire process validation phase
    • Operational Qualification (OQ)
      • Verify the manufacturing process achieves its operational requirements
        • Tests will determine the highest, lowest and medium operating parameters. Use the process parameters to set control limits and action limits – in order to determine whether the process is reproducible
        • Challenge this process by using worst case conditions. If OQ is successful, it validates the process control limits and action levels result in production – that meets predetermined requirements
    • Performance Qualification (PQ)
      • Final phase of the validation process
      • In this phase the equipment will run several times under normal operating conditions and functions will be challenged
      • The purpose of PQ is to demonstrate that the process, under anticipated conditions, consistently (long term) produces a product which meets all predetermined requirements for functionality and safety
Software Quality Testing Support

Challenges Teams Face

  • Poor or ambiguous requirements
  • Unrealistic project schedules due to scope creep
  • Lack of test team productivity and efficiency during early phase of the project
  • Insufficient impact analysis including risk assessment of modified code leading to incomplete regression test coverage
  • Time delays caused by test engineer work stoppage due to application implementation confusion
  • Rushed testing near project deadline causing critical defects to escape to production

Product/Project Capabilities

Whether it’s helping a team meet a short-term milestone or supporting an entire organization with a reliable quality assurance team across multiple projects – Advantu’s experts are ready and we can scale our team to meet your testing needs.

Advantu’s professional engineers have vast industry experience, which will ensure your product is released on time, within budget and with the quality your customers expect, over and over again.

Utilizing software quality assurance best practices, our team(s) provide dependable software testing support for mission critical systems across the technology spectrum.

We have over 60 years of IV&V experience with medical device, enterprise and life science mobile applications.

When you need experienced SQE/Test engineers who can ramp up quickly and blend seamlessly with your R&D team – Advantu is here.

For select clients, we provide Talent Sourcing/Candidate Vetting for Contract & FTE Engineering Roles.

Contact us today & ask how we can support your R&D Team with experienced SW Test Engineers – let’s get this turned around in your favor!