COMPLIANCE ADVISORY
Australia Therapeutic Goods (Medical Devices) Regulations 2002 Readiness Advisory
Score your readiness for free, then turn the results into a plan in a 30-minute strategy call with Ivanka, co-founder of The Art of Service, which has trained 54,000+ professionals across 160+ countries.
Why work with Ivanka on Australia Therapeutic Goods (Medical Devices) Regulations 2002
Australia's Therapeutic Goods (Medical Devices) Regulations 2002: the essential principles, classification rules and conformity assessment procedures for medical devices and IVDs, the automatic conditions on ARTG entries (adverse event reporting periods, complaint and distribution records, annual reports), exemption and clinical trial conditions, mandatory healthcare facility reporting and the…
Compliance work stalls when it is treated as a checklist. Ivanka treats Australia Therapeutic Goods (Medical Devices) Regulations 2002 as a strategic decision: what matters most for your organisation, what to do first, and what your leadership team needs to understand. For 25 years she has built The Art of Service, whose compliance platform now covers 1,062 frameworks.
The free readiness assessment scores your organisation against the 67 controls across 11 domains of Australia Therapeutic Goods (Medical Devices) Regulations 2002. The strategy call turns those scores into priorities.
Relevant credentials
- Co-founder of The Art of Service, which has trained 54,000+ professionals across 160+ countries
- MIT Entrepreneurial Masters Program graduate
- EXIN Expert Panel member
THE STRATEGY CALL
What you get in 30 minutes
Ivanka reviews your Australia Therapeutic Goods (Medical Devices) Regulations 2002 readiness scores with you and agrees which gaps matter most. Specific to your results, not generic advice.
A clear, prioritised plan for addressing gaps across 11 domains: what you can build on from existing work and what needs new investment.
How Australia Therapeutic Goods (Medical Devices) Regulations 2002 fits with the other obligations you already manage, so it strengthens your existing programme instead of running beside it.
Domains covered in Australia Therapeutic Goods (Medical Devices) Regulations 2002
Plus 5 additional domains. See the full assessment →
This is for you if
- You need to achieve Australia Therapeutic Goods (Medical Devices) Regulations 2002 compliance but don’t know where to start or how to prioritise
- You’ve been told you’re “compliant” but suspect gaps exist that haven’t been properly assessed
- You manage compliance for medical device manufacturers, australian sponsors and importers of medical devices, ivd manufacturers and pathology laboratories making in-house ivds, software as a medical device developers, australian conformity assessment bodies, hospitals and day hospitals, clinical trial sponsors and sites, custom-made and patient-matched device makers such as dental laboratories organisations and need expert guidance, not generic templates
- You want to leverage existing compliance efforts across multiple frameworks rather than starting from scratch
- You need a strategic plan your leadership team and board will actually understand and support
Start with a free assessment. Then let's talk strategy.
Take the free Australia Therapeutic Goods (Medical Devices) Regulations 2002 readiness diagnostic. In 5 minutes you'll have a clear picture of where your gaps are. Then book the strategy call and Ivanka will help you decide how to close them.
Free · No login required · Results in 5 minutes
Or go directly to the $149 Report + Strategy Call