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Business Challenge
The client is a leading regulatory consulting firm, specializing in global medical device and IVD compliance. They not only help organizations in transitioning to new regulatory schemes but also work towards reducing process time. They ensure quality that meets global regulatory standards to obtain quick approvals.
Solution Delivered
Fission Labs developed a Regulatory Compliance Management Platform specially designed to cater to the customers in the core medical device regulatory management. We worked with the client to develop compliance-focused regulatory results to serve their wide customer base. We helped them achieve greater efficiency & speed up the Medical Device FDA approval process with suite’s advanced report generation techniques.
The Business Benefits Rendered
Over 17000 Device Companies are active on the platform.
Efficiently tracked 13000+ Regulatory Certificates.
100k+ devices placed in the market by the client company.
Salient Features of the Platform
Streamlined Medical Device Regulatory Processes
Hassle-free certification expiry management and monitoring
Simplified digital interface
Smooth and accelerated FDA approval process
Innovative report generation techniques