MedSecTesting

CYBERSECURITY TESTING FOR MEDICAL DEVICES • Penetration testing for Software as a Medical Device and Medical Devices that include Software. • Penetration testing for Wearable and IoT Medical Devices. • Binary, dependencies, and source code analysis for security breaches. • Cloud infrastructure and backend security assessment. • Cybersecurity risk assessment compliant with FDA, TGA and EU MDR requirements. While testing, we follow regulatory bodies, OWASP, CIS and ISO security testing guidelines. Our team is certified Penetration Testers and Information Security professionals. We provide all the required documentation related to cybersecurity for your pre/post-market submission. We have completed numerous cybersecurity testing projects that have been successfully approved by FDA, TGA and EU MDR regulatory authorities. With us, you will be confident that there are no blocking security issues for your device to get on the market. Our approach: 1. Initial meeting to discuss high-level requirements. 2. Signing Non-disclosure (NDA) and Intellectual property (IP) agreements. 3. Gathering detailed requirements via: a. Meeting the core team, b. Existing documentation, c. Follow-up emails. 4. Preparing a detailed and compliant Test Plan. 5. Designing the most effective test cases for your device. 6. Executing the security testing according to the approved Test Plan. 7. Preparing technical test reports with findings and mitigation recommendations. 8. We assist your technical team addresses the issues according to the recommendations. 9. Our test team re-test the failed modules and prepare the final report