● Australian-based regulatory & clinical consulting
We help medtech and biotech companies navigate regulatory submissions, quality audits, clinical trials, and product development — from strategy through to outcome.
The problem we solve
Most companies hit a wall. A submission is due, an audit is looming, a clinical program needs to launch — and the internal team doesn't have the senior experience to get it across the line.
Agencies are slow and expensive. The work lands with a junior. You get a document, not an outcome.
Cyon Medical comes in at the senior level, builds the strategy, directs the execution, and delivers the result.
What we do
End-to-end regulatory strategy, submissions, and quality systems across major global jurisdictions. We build the strategy, execute the plan, and get the approval.
Multi-jurisdiction submissions and strategy. Classification, technical files, labeling, advertising compliance. International market entry — including TGA for companies entering Australia.
ISO 13485 QMS design, build, and management. External audit preparation and oversight. Post-market surveillance, risk management, vigilance reporting, DHF/DMR/DHR documentation.
Regulatory strategy and hands-on oversight for clinical studies across AU, US, and UK. Device and medication-linked studies at scale — from ethics through to data.
Engineering leadership across hardware, firmware, embedded systems, SaMD, and connected devices. Multiple international patents. Registered Professional Engineer. Technical and regulatory — natively bridged.
Senior project and program management across medtech and pharma. Contracts, MOUs, SOWs with major pharmaceutical partners including global pharma. Cross-functional leadership — engineering, clinical, software, quality, manufacturing — from strategy through to signed outcomes.
How we work
We understand your problem, your constraints, your team, and what success looks like. No assumptions. No templates. We map the exact regulatory and clinical path for your product and your market.
We build the strategy and project plan, then work directly with your teams to deliver it. Senior involvement throughout — not handed off once the engagement begins. The work gets done.
Submission lodged. Audit passed. Trial running. Product registered. We measure success by results — not hours billed or documents delivered.
Get in touch
Tell us briefly what you're working on and what you need. We'll come back to you directly — no intermediaries, no delay.