Product Registration Tracking

With the medical technology industry facing increased margin pressures, evolving demands from the FDA and other regulatory bodies along with greater competition, medical device manufacturers need to operate more efficiently and effectively. Regulatory affairs product registration tracking is an area that carries great potential for manufacturers to boost productivity, cut costs and mitigate risk. A growing number of medical device manufacturers are achieving greater operational and financial performance by automating their FDA medical device registration tracking processes.

Integrating Medical Device Tracking Software In The Enterprise

Sparta Systems' product registration tracking system enables medical device manufacturing companies to significantly reduce effort, cost and risk associated with the registration process. The system improves the management, tracking and reporting of global registration activities while reducing time and cost. It is the only regulatory affairs software solution that can effectively streamline the highly complex product data relationships that are typical of registration data as well as integrate with other quality and compliance processes within the organization.

Global Medical Device Tracking Technology

Sparta Systems' software solution optimizes the management of product life cycle activities for each registration, in each country, and for every product, intended use, configuration, kit and associated labeling. With the product registration solution, tracking the entire lifecycle of the product registration process becomes fully transparent across the global organization, bringing products to market with greater speed and efficiency, while ensuring FDA and other regulatory compliance requirements are met.

 "Medical Device Registration Tracking Process" 
 

Medical Device Requirements 

Benefits 

 
Tracking of regulatory activities across multiple sites and geographic locations
 
 
Automatic monitoring of all regulatory submissions, correspondence and commitments
 
 
Meet global regulatory requirements & updates
 
 
Quick adaptation to changing global regulations through easy point and click configuration
 
 
Provide detailed information quickly and effectively
 
 
Efficient search and fast report generation with automatic distribution
 
 
Selective viewing of data/information via tabs or data fields
 
 
Configurable fields to manage variety of data/information entries/reference documents
 
 
High accuracy of all registration information and submission files
 
 
Enhanced organizational visibility to global product information for strategic business and compliance decisions
 
 
Reduce costs by eliminating redundant technology applications
 
 
One centralized system to share global product information
 

 

Medical Device Product Registration Tracking

Utilizing Automation to Gain Business Efficiencies with Product Registration Tracking

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