Years of Experience
Successful Registrations
Clients Served
Compliance Rate
What We Offer
Comprehensive Regulatory Services
From initial device classification to post-market compliance, we provide end-to-end regulatory support for the Australian market.
ARTG/TGA Registration
Complete management of your Australian medical device registration, from classification through to ARTG inclusion.
Strategic Regulatory Planning
Comprehensive regulatory strategy for medical devices and IVDs, covering Australian and international market requirements.
Product Labelling Reviews
Expert review of medical device and IVD labelling to ensure compliance with TGA requirements and Essential Principles.
Quality System Audits
Thorough internal audits of your quality management system to maintain compliance and identify improvement opportunities.
Post-Market Surveillance
Systematic post-market monitoring and reporting to meet ongoing TGA obligations and ensure continued device safety.
Australian Sponsor Services
Legal Australian Sponsor representation for international manufacturers, managing all in-country regulatory obligations for your ARTG listings.
Why Servi-Star
The Partner You Can Trust
When regulatory compliance matters most, our decades of experience and deep industry connections set us apart.
Proven Expertise
Four decades of management experience delivering high-level quality and regulatory systems in the healthcare industry.
End-to-End Knowledge
Sound regulatory knowledge spanning the entire product lifecycle, from development through to post-market surveillance.
Industry Connected
Professional Member of LifeSciences Australia Ltd, the national peak body representing life sciences professionals.
Efficient Results
Streamlined processes that reduce time-to-market while maintaining the highest standards of regulatory compliance.