Emerging leader in ophthalmic medical devices selects clinivation enterprise solutions for accelerated global market access and comprehensive global regulatory intelligence.
NATICK, MA – January 22, 2013 – Clinivation, Inc. is pleased to announce today that OptiMedica 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.
OptiMedica Corporation is a Silicon Valley-based global ophthalmic device company dedicated to developing performance-driven technologies that improve patient outcomes. The company was founded in 2004 with the vision of bringing innovative new technologies to ophthalmologists and transforming existing standards of care.
Since its founding, OptiMedica has been developing a reproducible, noninvasive technique to replace the inconsistent manual steps in cataract surgery with femtosecond laser technology. The system has been designed to deliver new levels of precision, control, performance, and efficacy to cataract surgeons and their patients. OptiMedica has completed clinical trials of its Catalys™ Precision Laser System, with very promising results reported across these measures.
OptiMedica has a legacy of delivering transformational change in ophthalmology. The company’s initial commercial effort was in retina, where its research and development team sought to rethink panretinal photocoagulation (PRP) to dramatically improve the precision, efficiency and comfort of the procedure. OptiMedica licensed pattern scanning laser technology from Stanford University, and its PASCAL® (PAttern SCAn Laser) Method of photocoagulation transformed the retinal photocoagulation market.