Your Medical Device requires Cybersecurity Testing!
From October 2023, medical device companies must prove that their products (networked Medical Device, Medical Device that includes software and Software as a Medical Device) meet cybersecurity standards as per new Food and Drug Administration (FDA) submission requirements. Applicants are required to provide assurance that the device and related systems are secure or risk rejection.
Similarly, the Therapeutic Goods Administration (TGA) and the European Union's Medical Device Regulation (EU MDR) mandate that manufacturers demonstrate compliance with cybersecurity standards to obtain market approval.
Our team will assist in preparing your Medical Device for submission cybersecurity-wise. We will cover:
1) Risk Assessment & Thread Modeling
2) Penetration Testing
3) Source Code Analysis
4) Cloud Infrastructure and Backend Assessment
5) Technical Design Security Assessment
And we will provide all the cybersecurity-related documentation required for the submission so you can prove the security assurance.