Software Testing for Medical Devices (IEC 62304)

IEC 62304 MEDICAL DEVICE & APPLICATION TESTING | ASSURED CONFORMANCE | INDEPENDENTLY VERIFIED
IEC 62304 - Medical Software Testing

Software Testing checks that a given program correctly implements requirements to the IEC 62304 standard.  IEC 62304 is applicable to all software for medical devices and applications and covers the processes and activities around the production of embedded and free standing software.

Developing an effective, efficient in-house testing capability to validate and test to this depth is time consuming, expensive and requires detailed experience of testing to this level.

Why Test IEC 62304 Independently?

  • Independent testing of software provides assurance that verification standards have been achieved
  • Protect the reputation of your products by independent testing
  • Independent expert consultants can verify the process and activities
  • Independent testing resources are available when you need them and only then

The T&VS Software Testing solution

The T&VS asureTEST services help you to establish a cost-effective software testing facility, with experience in testing medical equipment software, that delivers assured, verified quality and reduced time-to market.

  • Resources: Flexible resource proficient in testing methodologies and tools
  • Products: Requirements-driven testing and signoff through asureSIGN
  • Consultancy to improve test methodology or continuous improvements through benchmarking
  • Training in the software testing techniques and management.

Case Studies

The following are T&VS case studies showing our work in safety critical embedded medical software, medical mobile apps and medical data security

Find out more

Contact one of our medical software testing consultants today. No hard sales, just pertinent questions to understand your medical device testing requirements so that we can help you take the next steps.


Alternatively call one of our local sales offices, email us or subscribe to our ‘Intelligent Testing’ newsletter covering software testing.