Make your Medical Device FDA, TGA and MDR Cybersecurity requirements compliant
Regulatory bodies (like FDA, TGA and EU MDR) require a cybersecurity strategy for every new medical device submission which includes detailed procedures for monitoring, updating, patching, and remedying the devices.
Our team can assist cybersecurity-wise with the pre-market submission and the post-market support. We will cover:
1) Security Risk Management which involves conducting thorough risk assessments throughout the device's lifecycle, from design and development to post-market surveillance.
2) Documentation detailing the cybersecurity risk management processes, including risk assessments, mitigation measures, and any changes or updates made to enhance device security. Moreover, the security testing documentation (penetration testing and infrastructure assessment) including Test Plans, Test Protocols, Technical Reports with the remediation strategy and the Test Summary Report should be provided to facilitate any concerns raised by the regulatory bodies.
3) Software Bill of Materials (SBOM that includes details of commercial, open-source, and off-the-shelf components your team used to build the device’s functionality.
4) Design Controls that address cybersecurity risks from the outset, incorporating security features such as encryption, authentication, and access controls to safeguard sensitive data and prevent unauthorised access to the device. This should be highlighted in the Secure Product Development Framework (SPDF).
5) Software Validation and Testing including vulnerability assessments, penetration testing, and validation of security controls to identify and address potential weaknesses that could be exploited by malicious actors.
6) Incident Response Plan outlining procedures for detecting, reporting, and mitigating security incidents.