Software validation for medical devices refers to the process of ensuring that the software used in medical devices meets the specified requirements and operates correctly and reliably. It involves a set of activities and tests to verify that the software functions as intended, performs accurately, and complies with regulatory standards and guidelines.

Mobile application testing for medical devices specifically focuses on testing the software applications designed for use on mobile devices in the medical field. This testing ensures that the mobile app functions correctly, maintains data integrity, and provides a safe and reliable user experience. It typically involves testing various aspects such as functionality, performance, security, usability, and compatibility across different mobile platforms and devices. The objective is to identify and resolve any defects or issues before the mobile application is deployed for use in the medical device ecosystem.

Software validation and mobile application testing are vital tools used to assure the quality of medical devices and helps result in fewer recalls and corrective actions, less risk to patients and reduced liability for medical device manufacturers. Let us help you streamline the testing process, tighten up test plans or take on some of the testing when your team is overtaxed and up against a deadline.

Our testing capabilities includes:

  • Functional Safety Testing - functional capabilities of software including healthcare workflows
  • Conformance Testing - industry frameworks and security requirements (Meaningful Use, HIPAA, FDA requirements, VA requirements)
  • Interoperability Testing - conformance to DICOM, HL7, CCD/CDA using industry standard testing tools
  • Load and Performance Testing - testing software load time and performance
  • Cybersecurity Testing - meet regulatory requirements for secured medical product and solutions
  • Claims Testing - marketing related claims for features and overall use

Related Links

Cybersecurity in Medical Device

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