Lucent Clinical Consulting LLC Logo - medical devices

Lucent Clinical Consulting LLC

medical devices
China's Best One-Stop Medical Equipment Provider
About

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: • [email protected]

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Keywords
clinical research class iii gcp biotechnology regulatory submissions iso 20196 medical device class ii code of federal regulations 510 premarket application mdr clinical operations risk management validation iso 14155 clinical trials good clinical practice regulatory standards fda ivdr gcp consultant medical devices & equipment clinical protocol design consulting research and development in the physical engineering and life sciences regulatory compliance regulatory standards change
Company Information
  • Employees 1
  • Founded 2020
Location

Minneapolis, Minnesota, United States, 55415

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