Tietronix can help your project navigate the maze of medical regulations and standards and achieve success. If your project needs to step up to the next level or is in need of rescue Tietronix can help.
Initial product development phases focus on the problem more than the process and logistics. When projects reach the point of satisfying FDA and international regulations, they face the challenge of proving their process is as good as their software. This task can be overwhelming with the maze of regulations and standards required for compliance before product release.
The project must maintain project schedules, requirements, design capture, design input/output reviews, risk analysis, testing protocols and other objective evidence in a design history file. Tietronix can assist at any phase of the project to bring the device up to standards, document the required details and ensure compliance with necessary regulations. Our team of medical device experts using our proprietary Quality Management System (QMS) product suite can bring seamless compliance and superior product performance to your medical device.
Tietronix has the expertise to bring your product to the level of documented compliance and performance needed to excel in the market of choice.