Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm

Get In Touch:

Get In Touch:

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

Cybersecurity for Medical Devices

FDA –Food and Drug Administration

Security Requirements

Vulnerability Testing – Evidence on the Testing of Malformed

THE FDA’S ROLE IN MEDICAL DEVICE CYBERSECURITY

Dispelling Myths and Understanding

Download the Fact Sheet (PDF – 175kb)

04/07/2022 Draft Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

EU MDR and IVDR

FAQs

How can we protect heath care from Cyber-Attacks?

·   Vulnerability assessment and required testing
·   Training health care providers to protect from any breaches
·   Follow the standards of the regulations

Where is Cybersecurity used?

Cybersecurity helps in protecting the Datas, software or hardware connected with the system. This reduces unauthorized access to the data or the system.

What is the PATCH act?

PATCH act helps to meet all the Cybersecurity requirements for the manufacturer to complete FDA regulation standard.

What medical devices can be hacked?

MRI, Pacemakers, Implants, Heart rate monitors, Drug infusion pumps, medical records and other devices connected to the hospital network.

What are the new cybersecurity requirements according to EU MDR?

MDR Annex I explain the risks associated with the interaction between software and medical devices. Manufacturers should follow standard during life cycle, risk management, verification, and validation of the devices.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Prev post
Next post

Leave A Reply

Enquiry Now


    This will close in 0 seconds