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Current company Novare Medical Consulting
Business Consulting and Services · 4 employees · Founded 2021 · Lafayette, Colorado, United States
Novare Medical Consulting, founded in 2021, is a consulting firm providing consulting and advisory services for the medical device industry. Comprised of former managers, directors, and VPs from multiple segments of the industry, we provide expertise and guidance for Product Development, Quality Management, Manufacturing, Clinical, Regulatory Compliance, and much more. Novare Medical Consulting is a senior-level medical device consulting firm providing executive quality, regulatory, and R&D leadership to manufacturers ranging from start-ups to global organizations. Our team brings decades of hands-on experience in: • FDA 21 CFR 820 compliance • EU MDR Technical Documentation • ISO 13485 & MDSAP readiness • 510(k), PMA, and global submissions • Inspection readiness & audit defense • CAPA & complaint system remediation • Design Controls & Risk Management (ISO 14971) • Post-market surveillance & MDR reporting • Supplier quality & operational excellence • Full lifecycle product development We have supported Class I, II, and devices across orthopedic, spine, interventional, infusion, surgical, and implantable technologies. Our leadership team has: • Served in executive roles (Global Director, Program Director, Engineering Manager, Principal Consultant) • Managed global product portfolios exceeding hundreds of SKUs • Led successful FDA and Notified Body inspections • Rebuilt Quality Management Systems • Guided EU MDR transitions • Filed and cleared 510(k)s • Managed large-scale remediation efforts • Launched first-of-their-kind medical technologies We don’t just advise — we execute. Whether your organization requires remediation support, global expansion strategy, interim executive leadership, or full QMS transformation, we provide practical, regulator-ready solutions aligned with business objectives.