Bring Devices to Market Efficiently
Download R&Q's white paper on how to utilize TPLC reports.
The intention behind the FDA's Total Product Life Cycle (TPLC) report is to provide existing data to medical device manufacturers that will enable them to proactively address quality related issues as early as possible. Companies should have quality systems that incorporate TPLC information into all aspects of their system; such as supplier qualification/monitoring, risk management, design controls, corrective and preventive action, and complaint handling. Incorporating this information throughout the entire life cycle of the device will bring devices to market more efficiently and with less issues post-launch.
In this white paper you will learn how to:
- Calibrate and strengthen non-filing justification documentation for design changes
- Design solid verification and validation and clinical testing plans
- Proactively investigate similar potential problem areas
- Understand the recall and MDR position of competitors and calibrate on industry practice
- And much more!