Design Controls

 Design Controls (Medical Devices)

“Design Controls” refers to several processes and procedures that the manufacturers need to follow when designing and developing medical devices.  These formal design parameters outlined by the FDA regulatory authorities must be implemented and followed throughout the design development lifecycle of the product. This gives manufacturers the opportunity to address problems early on, thereby preventing loss of time and money. 
 
ADB Consulting’s design controls validation service help the companies comply with the design control requirements of the FDA. Our customized and comprehensive validation services ensure that the manufactures are using technologically feasible and safer design for the product. We also generate design history and technical documentation citing evidences that can be produced by the companies in the event of litigation to demonstrate that the risks associated with alternative designs were evaluated and considered.
The team of ADB Consulting with its in-depth knowledge of FDA regulations and advanced capabilities can help you with the following services:
Planning and execution of design projects
Design input/output 
Design verification and validation
Design transfer to a contract manufacturer
Risk assessment
Risk management
Safety and environmental control requirements
Change control
FDA and GMP requirements
Design history and documentation
 

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