Effiziente Entwicklung Ihrer Medizinprodukte

Aligned Elements - das Medizinprodukte ALM für Ihre Design History File Dokumente

  • Reduzieren Sie die Zeit, die Sie in Dokumention investieren müssen
  • Setzen Sie Resourcen für Innovation frei
  • Bleiben Sie konform zu den Normen, Standards und Direktiven


Cybersecurity, pacemakers and recalls

Cybersecurity issues resulted in 465 000 St Jude pacemakers being subjected to a FDA recall due to fears of exploiting existing cybersecurity vulnerabilities in the device. A security hole exposes the device to hacking risks, potentially resulting in running the batteries down or even alter the patient’s heartbeat.


Although the risk is extremly low, the cost for St Jude / Abbott is significant. For a smaller firm these ramifications can be detrimental. The long life time of medical devices and an ever evolving cybersecurity arena makes devices vulnerable to cyber risks. Handling them effectively will be a significant challenge for the industry in the years to come.

We are addressing Cybersecurity issues in the Supply Chain during a Key note at the Swiss Medtech Expo in Luzern, 19-20 September.

Join us for this key note or come and meet us at the Expo at Booth B2045, Halle 02.

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