BIOVERA

BioVera's services include preparation and execution of FDA and Health Canada regulatory submissions for orthopaedic devices, including pre-submissions, 510(k) notifications, planning and management of pre-clinical testing and reporting, devising strategies for maximizing utility of test data for regulatory requirements and product marketing, advice on technical file preparation in support of CE Mark, class 3 device strategy and FDA applications, and Medical Device Licence Applications for class 2, 3, 4 orthopaedic devices (Canada)... BioVera also offers expert advice and strategy in applying new and existing biomaterials to orthopaedic devices with consideration of product performance and regulatory requirements. Examples include ceramics, cross linked & stabilized polyethylene, and monoblock technology to reduce wear and improve performance of arthroplasty implant devices... BioVera, LLC and BioVera, Inc. provide medical device and biomaterial testing, research, development, and..

Also known as: BioVera, LLC