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Medical Device Software Testing

Be Confident in Your Medical Device Software

Having 19 years of experience with healthcare and 35 years in testing, ScienceSoft helps medical device manufacturers and software providers ensure the quality of medical device software and its compliance with regulatory standards.

Medical Device Software Testing - ScienceSoft
Medical Device Software Testing - ScienceSoft

Medical device software testing is a way to guarantee the solution’s quality by verifying its requirements and architecture and checking if it meets user needs.

ScienceSoft’s Testing Center of Excellence has accumulated working best practices for testing medical device software. Our team will eagerly implement them to help you smoothly introduce your software to the market or confirm its compliance.

Scope of Our Medical Device Software Testing Services

Companies we serve

  • Medical device manufacturers.
  • Medical device software providers.
  • Healthcare providers.
  • Pharmaceutical companies.

Medical devices we test

  • Class II – medium-risk medical devices (CT scanners, wearable glucose monitors, blood pressure monitors, wearable ECG sensors, etc.).
  • Class III – high-risk medical devices (pacemakers, cardioverter-defibrillators, deep-brain stimulators, etc.).

Testing types we excel at

Our Testing Projects for Healthcare

We Know the Importance of Thorough Documentation

ScienceSoft understands that you need complete and comprehensive test documentation and provides you with the following deliverables:

  • A test plan with clearly identified pass/fail criteria.
  • Test cases and automated test scripts.
  • Defect descriptions.
  • The description of verification and validation activities performed at the API, integration and system levels.
  • A system-level test protocol with pass/fail criteria.
  • A test results report.

Who We Are in Numbers

  • 19 years

    in healthcare IT

  • 35 years

    in software testing services

  • 730+

    testing projects

  • 23 years

    in test automation

  • 65%

    of test engineers have 10+ years of experience

Why Companies Trust Us

  • ISO 13485:2016 certified to guarantee testing compliance with the requirements of the FDA and the Council of the European Union.
  • ISO 27001 certified to guarantee the security of sensitive information and test data.
  • Team with hands-on experience in HIPAA, HITECH and FDA requirements and healthcare data exchange standards (e.g., HL7, ICD-10, CPT, XDS/XDS-I).
  • Experience in FDA/CE registration.
  • ISTQB-certified test engineers and Doctor of Medicine consultants on board.

Benefits of Testing with ScienceSoft

-20-40% testing costs

due to:

  • KPIs-based testing, tailored to software specifics.
  • Reusable test cases.
  • Prioritization of testing activities based on the software intended use and risks.

Zero penalties

due to:

  • 100% regulatory compliance of medical device software.
  • Lack of software-driven malfunctions due to comprehensive testing.

Decreased rate of medical device recalls

due to:

  • Result-oriented and thorough testing of your medical device software.
  • Complete and comprehensive test documentation.

Having Doubts About Third-Party Testing? Let Us Change Your Mind!

During medical device software testing, there is a risk of disclosing patients’ health information and breaching HIPAA regulations. How can a third-party vendor handle security issues?

During testing projects, we at ScienceSoft apply VPNs, SSL certificates, encryption protocols, etc. The safety of our internal infrastructure is confirmed by ISO 27001 certification.

Will an outsourced testing team be able to swiftly dive into the specifics of our medical device software?

ScienceSoft has multiple successful projects in medical software testing under its belt and guarantees a quick transition. We effectively collaborate with other teams involved in your project so that no business or technical specific gets missed.

Apart from that, ScienceSoft’s testing engineers have working experience with major healthcare regulations (HIPAA, HITECH, ONC, MACRA, MIPS, CEHRT, SAFER) and healthcare data exchange standards (e.g., HL7, ICD-10, CPT, XDS/XDS-I).

Will we be able to track the testing process of our medical device software?

ScienceSoft ensures full transparency over the testing activities, offering detailed reporting and providing test documentation required by ISO 13485 and ISO/IEC/IEEE 29119-3:2021.

We Can Cover Any Testing Need

ScienceSoft’s healthcare testing professionals will:

  • Verify the quality of medical device software requirements.
  • Test medical device software at the API, integration, and system levels.
  • Verifying that software architecture is secure.
  • Perform software code review and code analysis.
  • Run user acceptance testing.
I need this!

Compliance testing

ScienceSoft’s compliance experts will help ensure medical device software complies with required standards and regulations (e.g., FDA, HIPAA).

I need this!

Tools We Use to Test Software for Medical Devices

Ensure Your Medical Device Utilizes Quality Software

ScienceSoft’s healthcare testing experts will eagerly verify and validate your medical device software and ensure it complies with all the required healthcare standards and regulations.