Design control and product validation along with process validation represents a critical series of steps necessary to assure that a medical device will demonstrate itself to be safe and effective in terms of the product’s specifications.
FDA has, and with the implementation of the harmonized GMP, will continue to focus in on this area. Lack of appropriate design controls and design validation is a major source of regulatory actions on the part of FDA.
DBT assists your efforts by offering services in the areas of:
- Design and implementation of Design Control Procedures include Product/Process Specification development.
Relating user requirements to Design Inputs - Special functions related to design such as cleaning and disinfection for re-usable devices
- Understanding the principles of validation and verification
- Change Control System design and implementation.