Powerful, cross-functional Medtech collaboration.
Strategy, Pre-submission Support, Submission Consulting, Breakthrough, (510k, De Novo, PMAs, Global Submissions including MDR, etc.), Pathway Assessment
Prototype Design & Support
Cloud Support and Build, Consulting, Software Support, Turn-key cloud platform
Bookkeeping, Assurance, Tax
Clinical Protocol, Clinical Strategy, Biostat Support, Clinical Execution
Grant Support, White Papers, Literature Searches, Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER)
Research & Development Tax Credits
Consultations confirming R&D credit eligibility, SaaS platform paired with R&D tax experts.
Quality Management System Build & Support, Ad-hoc Quality Consulting, Audits, MDSAP Support, ISO 13485 Implementation, MDR Transitions
Contract Development & Review, Business Start-up, Intellectual Property
Regulatory & Quality Placement
Design for Manufacturing (DFM) feedback and input, manufacture, package, and distribute products
Biocompatibility, Pre-Clinical Efficacy Testing, and Experimental Surgery
Human Resource / Payroll Consulting
Benefits support, HR expertise, Payroll services, HR technology platform, and PEO