President
Current- CriTech Research, Inc. provides software engineering services for the FDA-regulated medical device industry.
- Specializing in development and validation of safety critical software for medical devices
- Providing software verification and validation as required by the FDA and EU for software – Unit, Integration, and Software System Testing
- Experts at assisting companies to remediate gaps in their software design history file, includingreverse engineering of requirements and design, through software safety and performing software verification and validation
- Proven process, strong management, and an exceptional track record with extensive experience in a variety of domains and systems
- 100 percent, first-time approval record with both the FDA and EU for the over 380 devices we have worked on