Our team has both clinical and business expertise executing concept to commercialization orthopaedic device and implant products. We provide human factors assessments, user needs validation, cadaveric lab logistics and protocols, partnerships with rapid prototyping firms and contract manufacturing firms, surgical technique advisory and authorship and pre-market relaease gap assessments and solutions.
With a core leadership team comprised of orthopaedic surgeon industry subject matter experts, we can help you further conduct VOC, product validations, business model assumptions and medical education. Whether you intend to help orthopaedic patients in the reconstructive segment, sports medicine segment, or trauma segment, our diverse team has the industry experience you are seeking to help you.
We can help ensure you bring your device or implant to market in a safe and efficacious manner. Our regulatory and compliance team provides you with orthopaedic industry expertise to help you execute your regulatory strategy, review and update filings, sign-off on labels, and maintain adherence to updated polices and standards.
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