The FDA guidance for Management of Cybersecurity in Medical Devices suggests that manufacturers perform a Risk Analysis approach to the cybersecurity management of there devices. Promenade Cybersecurity experts can assist you through the process, identifying and documenting the risks from your device's potential threats and vulnerabilities. We will help you to assess the potential impact to the end-users and patients, if the devices loses functionality or data integrity is compromised.
If your device can connect to a network, your device's vulnerabilities may be exploited to breach the security of the network, and that too will be addressed. We will advise you on suitable mitigation strategies to adhere to regulatory expectations, and the risk acceptance criteria established.
Promenade Software Security Experts can help you decide on appropriate cybersecurity activities for your device. Often several options are available to mitigate the determined risks, and your device specific technologies will be used to determine the best fit for you. We will provide the options for:
Promenade Software Services can guide you through the creation of the regulatory documentation to ensure your submission goes smoothly. We will collect the information for you, and help you:
Promenade Software has expertise and solutions to help you make sure your device is secure, and can pass the toughest regulatory audit.