Medical Devices - Minneapolis, Minnesota, United States
Lucent Clinical Consulting provides human clinical research expertise to medical device and in-vitro diagnostic companies to accelerate commercial launch of new products, ensure compliance to changing regulatory standards and protect core markets through a winning clinical strategy.STRATEGIC CLINICAL CONSULTANT SERVICES:• Define Clinical Program Strategy and Design Clinical Protocols for Medical devices (Class II, Class III, de novo, combination products, humanitarian device exemption)• Design Global Organizations and Grow High-Performing Clinical Teams• Perform Corporate Due Diligence for Clinical-Stage Medical Products• Define Commercialization Pathways for New Technology• Plan Clinical Evidence for New Products (market offense) & Core Products (market defense)• Execute Clinical Risk Management Methodology with Leading Indicators• Evaluate Clinical Quality System Compliance (architecture, audit, SOPs, templates, work instructions, training)CONTACT:• kimberly.oleson.consulting@gmail.com
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