Medical Device Testing

Life Science Industry Testing

Medical devices continue to grow in importance within the medical industry because they play an important role in the mission to improve the quality of life for many patients. Because these devices contain significant amounts of embedded software and must operate consistently and with a very low failure rate, Medical Device Testing is a critical part of ensuring performance and minimizing potential impact to patient and operator well-being.

  • Increase Application Quality – Testing earlier, smarter, and faster by leveraging SQA Solution’s experienced testing resources throughout your development cycle.

  • Accelerate Time-to-Market – Finding critical issues earlier and preventing delays that are caused by issues found late. Bugs detected and fixed early are less expensive and keep your project quality up and costs down.

  • Minimize Testing Costs – Pay only for what you need with SQA Solution’s On-Demand delivery model allowing you to tailor your testing solution to focus your budget dollars where they’re most needed.

Creating Solutions

SQA Solution specializes in medical device testing, verification, and validation services assuring that software fulfills the requirements, compiles with FDA regulations, and protects the safety of operators and patients. We help companies verify product design and test software at every stage of the development life cycle. From analyzing requirements and developing comprehensive test plans to code reviews, testing, compliance audits, and documentation, we can help you navigate the FDA medical device approval process.

Our skilled and highly qualified Quality Assurance team offers an end-to-end solution for your product testing needs, including:

  • Requirements Management & Traceability throughout the project life cycle.
  • Test Plan Development & Execution using industry-accepted automated tools, as well as customized manual solutions.
  • Test Case Creation that’s compliant with customer and regulatory requirements.
  • Quality Controlled Test Execution at the customer site or in our modern lab facilities.
  • Full Array of Auditing & Qualification services, including SAT, IQ/OQ/PQ, ISO 9001:2000, 13485 and Internal/External Corporate Auditing.
  • Software Process Improvement from Assessment and Recommendation to Design and Implementation of a Compliant Quality System.

Medical device qualities tested by black-box methods and white-box methods.
Test Target Black-Box Methods White-Box Methods
Computer-style
operator Console
Screens
Tones
Printouts
Keys
Trackballs
Mice
Operating-system
internals
Error counts
and status
Timing and
performance
Internal communications
protocol
Memory and structure
internals
Interrupt behavior
Code execution
Memory leakage
Input-output ports
Embedded
processor in a
device control panel
Lighted buttons
LCD output
LED indicators
Safety switches
and interlocks
Warning tones
Key responses
Interlock responses
Dual port communications
Error counts and status
Input-output ports
Interrupt behavior
Memory and structure
internals
Timing and performance
Code execution
Sensor status
Embedded processor that
drives motor
controls
Mechanical
movement
Interrupt behavior
Error counts and status
Dual port communications
Memory and structure
internals
Timing and performance
Code execution
Digital or analog
input-output ports
External
communications link
Screen errors Timing and performance
Protocol correctness
Error handling

 

Providing Expertise

SQA Solution understands how to apply strategies, tools, and processes used by quality leaders around the world. Whether your company has adopted TQM, Six Sigma, Lean Design for Six Sigma, or another disciplined methodology, you can count on us to make short work of the learning curve and consistently deliver outstanding results.

  • Specialized Device Testing Experts – In a highly regulated environment, it’s essential to have senior staff with specialized V&V expertise. We even provide training to our clients in state-of-the-art testing methodologies.
  • Extensive FDA & Clinical Experience – Our seasoned team members bring years of experience working in heavily regulated FDA environments. They understand the Quality System Requirements (QSR), 21 CFR Part 820 Medical Devices, as well as Current Good Manufacturing Practices (cGMP).
  • Efficiency in Multiple Development Environments – Our years of intensive involvement with Microsoft, Linux, Unix, and embedded environments give us the practical testing capabilities you need to succeed.
  • Increase Productivity & Efficiency with Automation – With our automated test tools, we can reduce the testing timeline significantly. We provide full regression testing, enabling you to speed up your time to market.

How SQA Solution Can Help You

Want to learn more about how SQA Solution can help you to create and implement your organization’s Medical Device Testing strategy? Contact Us to get detailed information about what’s included in our services. Request a quote from us today!

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