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Medical Device / Combination Products

Innovative Regulatory Solutions

What We Do

We help medical device / drug / biologics companies determine and pursue the best regulatory paths available to achieve efficient and successful market entry and  post-market compliance

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We welcome the opportunity to see how we can help you. 

Capabilities and Service

Regulatory Strategy / Product Development / Market Approval / Post-Market Compliance

Black Chess Pieces

Strategy

Creating and implementing comprehensive and workable regulatory strategies / gap assessments for diverse medical device and combination product programs

Laboratory

Development Support

Device development and preclinical testing support for medical device and combination products including electronic devices and software/digital health applications

Image by Glenn Carstens-Peters

Submissions

Submission authoring and FDA review management for investigational (IDE, IND) and premarket applications (PMA, 510(k), De Novo, HUD/HDE, device specific sections for IND, NDA, BLA)

Product Area Experience

Diverse product area experience

Cardiovascular / Orthopedic / Neurologic / General and Plastic Surgery

In Vitro Diagnostic Devices

Drug and Biologic / Device Combination Products

Software as a Medical Device (SaMD) / Mobile Medical Applications / Digital Health

ABOUT US

WCI MedTech was founded in 2020 with a vision to provide medical device, pharmaceutical and biologics organizations with expert regulatory affairs services for product development, market approval and post-market compliance. We specialize in helping clients develop regulatory plans and achieve regulatory milestones to bring medical technologies from bench to bedside.  

 

We aim to meet clients where they are to implement comprehensive and workable regulatory solutions; rejecting a one size fits all approach. Whether your organization needs help with a regulatory premarket submission, product development and testing, or meeting with a regulatory authority, we are here to help you through the process.

Bryce Whited, Ph.D. │ Founder and Principal Consultant

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Dr. Whited holds a Bachelor of Science degree in Materials Engineering, and M.S. and Ph.D. Degrees in Biomedical Engineering. Dr. Whited began his career as an FDA lead reviewer of Orthopedic devices (Center for Devices and Radiological Health) and concurrently served in the commissioned corps of the Public Health Service at the rank of Lieutenant. After three years of public service, Dr. Whited was employed in the medical device industry as a lead regulatory strategist and submission author of class II and III devices/combination products, and later as an executive industry consultant. Dr. Whited is the founder and principal consultant at WCI MedTech leads all consulting operations with assistance from collaborating industry experts.

CONTACT

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© 2023 by WCI MedTech LLC

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