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TheraNova, LLC Team >> Capabilities

TheraNova has a broad range of capabilities in the field of Medical Device development.

Through its in-house engineering staff and network of specialists, services, and suppliers, TheraNova has the expertise required for every step of the medical device design process, including:

Mechanical Engineering
(Catheters, Implants, Capital Equipment, Disposables)

Electrical Engineering
(Signal Conditioning, Power Management, Patient Isolation)

Software Engineering
(Signal Analysis, Micro-controllers, State Machines)

Silicone Molding

Rapid Prototyping

Electromechanical Systems Engineering

Failure Analysis

Biocompatibility Assessment

Materials Selection

Experimental Test Design

Manufacturing Fixture Design

Manufacturing Process Design

Data Analysis

Medical Device Documentation

Risk Analysis

Supplier Approvals

TheraNova's principals and staff have significant experience in the area of Regulatory Affairs for both 510(k) and PMA devices. TheraNova has also worked closely with leading reimbursement consultants in the industry.

TheraNova’s staff and spin-outs have conducted clinical research in the United States, Europe, and South America.

TheraNova is currently building an ISO-13485-compliant Quality System for Specification Development that will be audited later this year (2008). The Quality System is designed for flexibility to accommodate the wide range of projects and transferability to each of its portfolio companies. As TheraNova adds manufacturing capabilities, further ISO certification in the areas of contract manufacturing and distribution will be earned.