Cybersecurity in Medical Devices | Quality System Considerations and Content of Premarket Submissions

September 27, 2023

Exciting news for the MedTech Industry!

The FDA has just released its latest guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions“. This comprehensive document covers a wide range of devices with cybersecurity considerations, highlighting the importance of cybersecurity information in premarket submissions.

It’s a must-read for anyone involved in medical device development and regulation!

Compared to the 2014 FDA guidance, this document emphasizes secure device design and addressing emerging cybersecurity risks throughout the product lifecycle via risk management activities.

At Asphalion we are experts in MedTech!!

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