Protecting your medical device, the enterprise network and confidential data has really never been easy….but due to all the cyber security attacks….it is only getting harder.
Network defenses are constantly under attack from cyber criminals, hacktivists, and other disgruntled entities. DDoS attacks, malware, botnets, and other threats are becoming more complex and better orchestrated.
Customers hold their providers responsible for not protecting their information. Even a small vulnerability in your network or data center infrastructure can lead to major financial damage and loss of customer loyalty.
You need to design networks that achieve the greatest possible security resilience—the ability to resist attacks and bounce back when one occurs.
This includes:
• Evaluating the performance of new technologies like next-gen firewalls, IPS systems, DDoS mitigation, and the like against the realities of your own network and threat profile
• Validating your overall defenses and processes before deploying and over time
• Addressing new vulnerabilities introduced by virtualization and other major initiatives
It is what you do not know….. that can hurt.
Integra Systems, Inc., and it’s partners can provide FDA QSR Cybersecurity Audits.
These audits can provide guidance and insight needed to meet FDA compliance requirements. They will provide the following:
• An evaluation of the classification of medical devices to identify the appropriate regulations.
• Identify predicate devices that are similar and already have a FDA 510(k) clearance. Then the new device will be evaluated to understand if the security aspects or use model could be based upon the predicate.
• Review in-house FDA compliance, guidance, standards, testing, and other specific requirements needed to claim substantial equivalence to predicate devices.
• Analyze risk mitigation and processes in place.
• Build and maintain a compliance program that satisfies current requirements.
• Provide change internal change process management when standards change.
Integra Systems, Inc. additionally has conducted testing for many medical device companies to include quality of service, security, and RF mitigation to include co-existence testing. We have authored cybersecurity guidance documentation for regulatory submittal for several medical device companies.
See attached the most recent FDA guidance documentation.