Recalls due to software issues

News / Events

Reasons, Consequences and risk mitigation strategy


How quickly can you take action?


Due to increasing amount of digitalization and the intended use of software in the field of Artificial Intelligence, the software itself increases in complexity. As a result, it gets more challenging for companies to identify and to take appropriate measures ensuring product and patient safety. An incomplete or neglect of regulatory requirements can have serious consequences. Product recalls solely based on software issues are rare but definitely seen in daily life including all devastating effects for the affected company.

A validated software as well as adequate processes during the software development (Software Development Life Cycle) reduce the risk for patients and enhance the safety of your product likewise!

Well established and gapless functioning quality processes as well as a profound understanding of potential software associated risks are essential to respond to complaints in a timely manner. An established Track & Trace process offers you complete traceability of which product was delivered to whom of your customers. Only this knowledge enables you to react effective and to take efficient measures in case of a recall. Due to this reason you should ask oneself honestly today: 

  • How do I ensure the highest quality of my software while minimizing risks along the Software Development Life Cycle?
  • How fast can I react in case a recall is required?
  • Can I trace back the entire supply chain in my company without any gaps, enabling me to take appropriate and efficient measures?

Thescon is your partner with more than 10 years CSV experience in the pharmaceutical as well as in the medical device industry!










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