Referral Partners
Powerful, cross-functional Medtech collaboration.
Regulatory
Strategy, Pre-submission Support, Submission Consulting, Breakthrough, (510k, De Novo, PMAs, Global Submissions including MDR, etc.), Pathway Assessment
Product Development
Prototype Design & Support
Cloud Support
Cloud Support and Build, Consulting, Software Support, Turn-key cloud platform
Accounting
Bookkeeping, Assurance, Tax
Clinical
Clinical Protocol, Clinical Strategy, Biostat Support, Clinical Execution
Medical Writing
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
Quality Management System Build & Support, Ad-hoc Quality Consulting, Audits, MDSAP Support, ISO 13485 Implementation, MDR Transitions​
Legal
Contract Development & Review, Business Start-up, Intellectual Property
Regulatory & Quality Placement
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Contract Manufacturing
Design for Manufacturing (DFM) feedback and input, manufacture, package, and distribute products
Pre-Clinical
Biocompatibility, Pre-Clinical Efficacy Testing, and Experimental Surgery
Human Resource / Payroll Consulting
Benefits support, HR expertise, Payroll services, HR technology platform, and PEO