EXCO verifies software in regulated industries

Putting it through its paces

We make sure that software and its specific properties conform to requirements. Software, which is used in regulated industries and products, is subject to high restrictions. Because software is increasingly used in embedded and safety-critical sectors. It is all the more important to verify, validate and test software and systems in critical components.

Software verification describes the process of checking whether software fulfils the specified demands.

Specialists for software verification. Proven in the regulated field.


Verifying for the medical technology industry

To relieve the pressure on R&D departments

To verify and validate software products for the medical technology industry, EXCO provides its customers with specialized teams of outstandingly trained employees. The guidelines of the quality systems in accordance with ISO/IEC 13485 and 9001, FDA QSR, ICH Q7a and EU GMP guidelines are implemented reliably by these teams.

Global market leaders from the medical product and pharmaceutical industry rely on EXCO’s verification and validation processes. For both in-house and third-party developments. We increase the efficiency and quality of software. The pressure is taken off the R&D departments of our medical technology and pharmaceutical customers, costs and risks are minimized.

In detail, we can act as an accompanying advisor or verification/validation manager and undertake the following activities:

  • Coordination and project manager activities
  • Support of or independent creation of requirements
  • Coordination and creation of FMEAs or risk analyses
  • Creation and execution of manual tests (white-box and black-box tests)
  • Creation of scripts to carry out automated tests.
  • Tracing of documents and deviations in any tracking tools
  • Execution of document reviews and source code reviews
  • Validation of the test tools and excel applications needed for the tests
  • Creation of all other documentation required by the regulatory bodies to license medical equipment

 

Minimize risks. With our verification specialists.