President
CurrentCriTech 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● ISO 13485 / ISO 9001 certifiedCriTech Research provides tailored services to include software verification and validation, software safety/risk engineering, and software development. In addition, CriTech is an acknowledged industry expert on assisting companies to remediate gaps in their software design history file, including reverse engineering of requirements and design, through software safety and software verification and validation. CriTech's engineering staff has diverse backgrounds in microcontroller, PC-based systems, web-based systems, and mobile medical applications. CriTech was founded in 1994 and has successfully completed engineering services for over 450 medical devices and products. CriTech Research is ISO 9001 and ISO 13485 certified.
