Software validation in the medical device industry – A risk-based approach

Since the 2016 edition of the ISO 13485 standard, validation of software used in support of the company quality management systems has been required. The new requirement had an impact on the scope of systems to be validated as well as an organizational impact, now involving business functions with limited previous experience with software validation.

Since 2016 certified companies are likely to have the topic of software validation covered in their QMS and their software in a state of control. So, now is maybe the right time to ask yourself some key questions:

  • Is the validation process appropriately identifying and addressing risks on an ongoing basis?
  • Is change control appropriately and efficiently applied?
  • Is the software validation set-up efficient and cost effective?
  • Is the organization appropriately prepared to maintain the state of control?

With a deep and profound knowledge of software validation gained from working extensively within regulated industries, pharmaceutical and medical device, for many years, HERAX is the perfect counterpart in your continued effort of compliance in the IT space.

Please contact us for further information, an information meeting and references at This email address is being protected from spambots. You need JavaScript enabled to view it..