Our Services
End-to-End Regulatory Solutions
From initial concept to ongoing market compliance, our comprehensive suite of services supports every stage of your medical device regulatory journey.
Australian Medical Device Registration (ARTG/TGA)
We manage the entire ARTG registration process on your behalf, from initial device classification and conformity assessment pathway selection through to successful inclusion on the Australian Register of Therapeutic Goods.
What We Cover
- Device classification and risk assessment
- Conformity assessment body engagement
- Essential Principles compliance review
- Technical documentation preparation and review
- ARTG application submission and management
- Australian Sponsor obligations support
Strategic Regulatory Planning
We develop comprehensive regulatory strategies tailored to your product portfolio and market ambitions, covering both Australian and international requirements for medical devices and In Vitro Diagnostics (IVDs).
What We Cover
- Market entry strategy development
- Regulatory pathway analysis and optimisation
- International harmonisation guidance
- Regulatory intelligence and horizon scanning
- Timeline and milestone planning
- Regulatory risk assessment and mitigation
Medical Device & IVD Product Labelling Reviews
Our expert labelling reviews ensure your medical device and IVD products meet all Australian regulatory requirements, reducing the risk of non-compliance and market delays.
What We Cover
- TGA labelling requirements compliance check
- Essential Principles labelling alignment
- Instructions for Use (IFU) review
- Package labelling assessment
- Promotional material compliance review
- Labelling gap analysis and recommendations
Internal Quality System Audits
We conduct thorough internal audits of your quality management system to ensure ongoing compliance, identify improvement opportunities, and prepare your organisation for external assessments.
What We Cover
- ISO 13485 compliance assessment
- TGA manufacturing requirements review
- CAPA system effectiveness evaluation
- Design control process review
- Supplier management audit
- Management review preparation and support
Post-Market Surveillance
We help you establish and maintain effective post-market surveillance systems that meet TGA requirements while providing valuable insights for product improvement and risk management.
What We Cover
- PMS plan development and implementation
- Adverse event reporting procedures
- Periodic safety update reports
- Post-market clinical follow-up planning
- Trend analysis and signal detection
- Field safety corrective action support
Australian Sponsor & In-Country Representation
We act as your legal Australian Sponsor for ARTG listings, providing ongoing regulatory representation for international medical device and IVD manufacturers entering the Australian market. Our team manages all in-country obligations so you can focus on your global business.
What We Cover
- Australian Sponsor for ARTG entries
- Ongoing TGA liaison and correspondence
- Adverse event reporting and management
- Recall coordination and field safety actions
- Annual ARTG charge management
- Regulatory change notification and impact assessment
IVD Regulatory Compliance
Specialised regulatory support for In Vitro Diagnostic medical devices, addressing the unique classification, conformity assessment, and performance evaluation requirements for IVDs in Australia.
What We Cover
- IVD-specific classification guidance
- Performance evaluation planning
- Analytical and clinical performance evidence
- IVD technical documentation support
- Companion diagnostics regulatory strategy
- IVD-specific labelling requirements