Specialist Consulting in Regulatory, Quality & Product Development
NovaReg provides strategic and hands-on support across regulatory submissions, quality systems, and product development for diagnostics and medical devices. Whether you're preparing for a 510(k), navigating IVDR, or building a compliant QMS, we’ll partner with you to deliver practical solutions aligned with your business goals
Quality & Compliance
Build or refine a practical QMS aligned with ISO 13485 and MDSAP. Internal audits, gap analysis, and CAPA management. Practical quality support tailored to your growth stage. Read more.
Regulatory Strategy
Confidently navigate global regulatory pathways - FDA, TGA, IVDR, and beyond. Strategic advice for market access and ongoing compliance. Read more.
Product Development Support
Accelerate your innovation pipeline with structured design control, risk management, and evidence generation strategies. End-to-end guidance through design control, risk management, and performance documentation, supporting innovation from concept to launch. Read more.
Contact us
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