Medical Device/IVD Trials

Wakefield IVD team supports the following regulatory strategy and submission initiatives:
U.S.
– Legal Agent

– 510(k)
– Clinical Laboratory Improvement Amendments (CLIA) Waiver
– De novo Submission
– Investigational Device Exemption (IDE)
– Premarket Approval (PMA) 

 China
– Legal Agent
– National Medical Products Administration (NMPA) Product Classification and Registration
– NMPA Consulting
– NMPA Submission, Follow-Up and Secure License
– Type Testing Preparation, Submission and Oversight 

Wakefield supports a variety of medical device/IVD Clinical Performance Studies:

– Study Design and Protocol Writing
– Site and laboratory identification, qualification, selection and management

– Site start-up, monitoring and closeout

– IRB/Ethics submission/approval
– Electronic trial master file (eTMF) creation and management
– Database Development and EDC management
– Data Review and Management
– Kit Management
– Monitoring
– Statistical planning, data management and analysis
– Sample/Specimen Collection
– Final Report Writing