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!!
Contact us for all your MedTech needs: [email protected]
You can also schedule a free 30-minutes meeting: SCHEDULE A MEETING
