State-of-the-art medical device manufacturer selects clinivation enterprise solutions for accelerated global market access and comprehensive global regulatory intelligence.
NATICK, MA – December 9, 2010 – Clinivation, Inc. is pleased to announce today that Coeur has selected clinivation enterprise solutions for accelerated market access and comprehensive global regulatory intelligence.
Ever-proliferating and changing global regulations generate complex challenges of execution in global market clearance operations.
Mission-critical decisions are delayed, trapping new international revenue until market clearance process issues are resolved. Workflow is confounded as information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources are reconciled- and as definitive answers are sought. Governance is compromised as information gaps reduce assurance levels and impair risk management of clearance-related penalties, fines, and legal costs.
And the high level of business performance required to create value from ongoing medtech industry consolidation is not achievable, since global market clearance operations are incapable of rapidly completing new market clearance submissions for newly-acquired product lines.
Unlike repackaged RI databases designed for the pharmaceutical industry, the clinivation WorldView Enterprise Solution for On-Demand Global Regulatory Intelligence accelerates the market clearance cycle.
This is because clinivation WorldView is designed, optimized, and proven to accelerate the processes and workflow specific to the global market clearance operations for medical devices, diagnostics, hospital supplies, and dental supplies.
And the industry results are outstanding. In multiple customer impact studies, clinivation WorldView customers consistently report accelerating submissions by 30 to 90 days, compared to recent experience without clinivation solutions.
For more information on the clinivation Enterprise Solution for On-Demand Global Regulatory Intelligence and Client-Directed Case Research Solutions, please visit the clinivation WorldView homepage.
For more information on the clinivation Enterprise Solution for Global Market Clearance Management, please visit the clinivation Global homepage.
Coeur OEM is a state-of-the-art designer and contract manufacturer for the medical and commercial marketplace with manufacturing and assembly operations in North Carolina and Wisconsin. In addition to manufacturing and assembling its own proprietary line, the company offers a full complement of services ranging from design, molding, tubing extrusion, assembly and packaging of medical devices. Coeur OEM also provides regulatory support including 510(k) submissions and sterilization services to the medical marketplace.