Medical Device and Biologics Consulting
Strategic Innovation Partner
SPECIALTY SECTORS
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Biologic License Applications for human tissue products
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Wound Care Device and Biologics
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Women’s Health Device and Biologics
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Cardiovascular Devices including extracellular matrix repair patches, stents, and heart valves (heart valve expert in mechanical and biologically derived valves)
ABOUT
I am an expert in R&D requirements for BLA, PMA, IND, IDE, 510K, HUD, and HDE submissions and CFR Title 21.
I have managed multiple projects for Class II and Class III devices and tissue based biotherapeutics following CFR Title 21 and ISO 13485 guidelines for medical device design, development and production and ISO 14971 for the application of risk management for medical devices.
ABOUT US
Renovo Biomedical originated as a way to provide R&D services to inventors and small businesses to advance their products quickly and cost effectively. Consulting services are provided as needed with clear up front pricing.
Expertise provided by Renovo Biomedical is a result of over 20 years of experience in the medical device and biologic industry managing multiple projects and handling interactions with the FDA and other regulatory bodies.