Novare provides senior-level expertise across quality management, product development, regulatory compliance, and sustaining disciplines — delivered by Principals who have led these programs from inside medical device companies.
Our four pillars reflect the arc of medical device introduction: build the quality system, develop the product, navigate regulatory requirements, then sustain the product through commercialization.
In practice, these areas don't operate in isolation. A 510(k) submission requires a DHF (DDF) built under design controls. A QMS remediation often surfaces gaps that affect post-market commitments. A new product launch involves all four areas at once.
That's why Novare doesn't silo expertise. Each engagement is led by a Principal with primary responsibility for the pillars most relevant to the work, supported by colleagues with complementary depth.
Build a Quality Management System that scales with your organization — satisfying FDA QSR/QMSR, EU MDR, and ISO 13485:2016, while staying practical for your team to operate.
Explore Quality → ii.Design and develop your next product from concept through verification, validation, and design transfer. Design History Files (Design and Development Files) built to satisfy FDA, EU MDR, and ISO 13485 from day one.
Explore Development → iii.Chart your path to market and maintain it once you're there. FDA, EU MDR, and international submissions — plus inspection readiness and post-market obligations.
Explore Regulatory → iv.Keep your device on the market and your operations running. Sustaining engineering, process validation, supplier transitions, and the everyday work of keeping a commercialized device healthy.
Explore Sustaining →Most engagements involve more than one. Schedule a no-cost consultation and we'll help you scope what you actually need.
Schedule a Consultation →