MedReg Consulting

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Decisive Regulatory Affairs Consulting for​ Medical Devices

General Info

Decisive Regulatory Affairs Consulting for Medical Devices. MedReg will map and complete RA activities and plan and manage clinical validation.

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Decisive regulatory affairs consulting for medical devices in the areas of design & development. Testing. And submissions to regulatory authorities. Medreg provides practical and attainable strategic options and works to support the path to market that best fits the Client's objectives. Medreg consulting is your ONE stop shop for early DUE diligence research and reporting though design. Testing. Submission. And approval for commercial sale in target markets. Medreg will MAP and complete RA deliverables for the client enabling them to focus their resources on innovations in science to promote medical product services and technologies that improve the lives of patients worldwide. ​.

Amenities

Strategic Planning, Design Controls, Risk management, Verification and validation testing, Protocol design and testing, ​Unique Device Identification, FDA Submissions, 510(k) Submissions, PMA Submissions, CE Mark Technical Files, Global Registrations, Medical Device Software, System Integration, Risk-Benefit analysis, Laboratory Developed Tests, CLIA Lab Survey Support​, Clinical study planning, Clinical site selection, Clinical study coordination, Informed consent process, Data management, Literature reviews​, Clinical evaluation reports

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Marketing Consultants

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Details

Phone: (303) 242-3711

Address: Boulder, CO 80301

Website: Primary Website