,Freyr Australia Medical Devices Competencies
- Therapeutic Goods Administration (TGA) Interactions
- Pre-submission meeting with Therapeutic Goods Administration (TGA)
- Regulatory Consultation and strategic support
- Australian Sponsor Services
- Device and In-Vitro Diagnostic Devices Classification and Grouping Services
- Conformity Assessment Body (CAB) Liaising and approval support
- ARTG Listing for Class I Devices
- TGA Conformity Assessment and ARTG listing for Class IIa, IIb, III and AIMD devices and Class 2, 3, 4 IVDs
- MDSAP Certification Support for Australia
- QMS Establishment and revamp
- Mock Audits, Internal Audits, Training services
- Compulsory and other Audit support
- Annual renewal of licenses
- Post Approval Change Management
Explore Freyrrsquo;s comprehensive Australia Medical Devices services and ensure seamless regulatory compliance. Contact us today to simplify your ARTG listing and TGA approval process!
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
Robert Menadue
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company
Why Partner with Freyr?
![On-Time Submissions]( "On-Time Submissions")
RI-driven Regulatory Operations
![Proven Track Record]( "Proven Track Record")
Single Partner for end-to-end Regulatory Needs
![End-to-End Solutions]( "End-to-End Solutions")
Right First Time Submissions
![Trusted Local Expertise]( "Trusted Local Expertise")
Preferred Australian Sponsor
![Accelerated Market Access]( "Accelerated Market Access")
Local Presence in Australia
![Accelerated Market Access]( "Accelerated Market Access")
Device category Specific Experts
