Promenade Software Security Experts can help you on appropriate cybersecurity activities for your device. Using a risk based approach, several options are often available to mitigate the determined risks, and your device specific technologies will be used to determine the best fit for you. We will help you:
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 Services use state-of-the-art security designs from the cloud and financial industries and incorporated them into prebuilt solutions for medical devices. The designs include:
Promenade Software Services include expert Penetration Testing of your Medical Device. We will analyze your device and attempt to exploit vulnerabilities in your devices security.
White Box and Black Box testing will be performed to assess your security gaps.
The Cybersecurity Bill of Materials (CBOM) is a list of software components included in the device (including open source libraries and OTS software) that could be susceptible to vulnerabilities. This list is considered by the FDA as a critical element in identifying assets, threats and liabilities. Promenade can help you:
Promenade Software Services can guide you through the creation of the regulatory documentation to ensure your submission goes smoothly, whether for the FDA, MDR, or IVDR. We will collect the information for you, and help you create the necessary components in a way that satisfies both the U.S. and European regulations.