Medical Device & IVD Services

Wakefield Clinical Research provides regulatory and clinical research support for medical device and in vitro diagnostic (IVD) companies developing products for the U.S. market.

Our team supports sponsors from regulatory strategy and FDA interactions through study planning, clinical execution, data review, and final reporting. 

• Regulatory strategy and pathway assessment 
• FDA Pre-Submission (Q-Sub) support 
• 510(k) Premarket Notification 
• De Novo Classification Requests 
• Investigational Device Exemption (IDE) support 
• Premarket Approval (PMA) support 
• CLIA Waiver support for applicable IVDs 
• FDA meeting preparation and communications 
• U.S. Agent representation for international sponsors 

Wakefield provides flexible clinical research support across medical device and IVD development programs, including:

• Human factors and usability studies 
• Medical device clinical investigations 
• IVD clinical performance studies 
• Study design and protocol development 
• Site and laboratory identification and qualification 
• IRB coordination and study startup 
• Participant recruitment and enrollment 
• Site management and clinical monitoring 
• Specimen collection and laboratory coordination 
• EDC and data review support 
• Vendor and laboratory oversight 
• TMF management and quality review 
• Data analysis and final report support 
• Study closeout 

Wakefield supports human factors and usability studies designed to evaluate whether intended users can interact with medical devices safely and effectively. Our capabilities include protocol development, FDA interaction support, participant recruitment, simulated-use study execution, data analysis, risk assessment, and final study reporting.

Wakefield has completed a U.S. human factors validation study of an OTC medical device involving user self-selection, labeling comprehension, critical tasks, and simulated device use in an intended home-use environment. 

For IVD programs, Wakefield supports clinical performance studies involving clinical specimen collection, testing, and coordination with qualified laboratories and investigative sites.

We work with sponsors to align study execution with the intended U.S. regulatory pathway and submission strategy.

Wakefield can provide comprehensive medical device and IVD development support or complement a sponsor's existing regulatory, clinical, or data management team.

For international companies entering the U.S. market, our team provides U.S.-based support and direct coordination with sponsors, sites, laboratories, vendors, and regulatory authorities.

Developing a medical device or IVD for the U.S. market? Contact Wakefield Clinical Research to discuss your program.