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MediNova is an Australian-based medical device Quality and Regulatory consultancy supporting startups, scale-ups, and established manufacturers across the full product lifecycle. We help companies navigate complex global regulatory pathways with clarity, confidence, and speed.

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Who We Are

MediNova was founded to provide hands-on, senior-level Quality and Regulatory support without the overhead of large consulting firms. We work closely with our clients as an extension of their team, delivering practical, compliant, and commercially realistic solutions. With deep experience across design, development, and post-market phases, MediNova supports medical device and digital health companies from early concept through to global market access.

Our Experience & Approach

MediNova brings senior-level experience across international regulatory frameworks, including Australia (TGA), United States (FDA), Europe (EU MDR), United Kingdom (UKCA), and other global markets. Our approach is pragmatic and risk-based. We focus on what regulators expect, what your business needs, and how to get there efficiently. Every engagement is tailored. There are no templates without thinking.

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What We Do

Quality Management Systems (ISO 13485, MDSAP, QSR)
Risk Management (ISO 14971)
Regulatory submissions and strategy
Design controls and technical documentation
Clinical and performance evidence support
Post-market surveillance and vigilance
Supplier and internal audits
Regulatory remediation and gap assessments
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