Denis Dmitrenko
With a degree in Mathematics and a Master's in IT Management, Denis brings over 20 years of experience in delivering comprehensive software solutions and testing frameworks across various industries, including healthcare, government, and finance. He leads a team of engineers and testers dedicated to developing secure code and ensuring the quality and cybersecurity of the delivered solutions.
Since 2021, Denis has specialized in medical device field providing IEC62304 and Cybersecurity consultancy to the medical device companies. His team of cybersecurity experts focus on penetration testing and cybersecurity assessments for medical devices. The team has successfully completed numerous projects involving devices of varying risk levels, achieving enhanced security and acceptance by regulatory bodies such as FDA, TGA, and EU MDR.
Key service areas:
- Cybersecurity consulting for medical devices
- IEC62304 consulting and documentation
- Code- and Cybersecurity-wise consulting for premarket submission and post-market support
- Penetration testing for medical devices:
- Firmware
- Hardware
- UI & Fronted
- Backend
- Connectivity & Network
- Code analysis and vulnerability scanning
- Cybersecurity configuration assessment for medical devices
- Cybersecurity documentation design, including:
- Cybersecurity Strategy
- Cybersecurity Management Plan
- Risk Assessment
- Threat Modeling
- Cybersecurity Test Plan
- Test & Assessment Reports