SGB Consulting Services (Australia Market Access)
SGB Consulting Ltd
SGB Consulting Services offers expert regulatory affairs and quality assurance support for medical devices and IVDs. They specialize in global market access, TGA Australia compliance, and navigating complex regulations like MDR and IVDR.
SGB Consulting Services, operating as SGB QA/RA Consulting Ltd, is a specialized consultancy focused on global market access and regulatory compliance for medical devices and In Vitro Diagnostic (IVD) products. With extensive experience, they assist clients in navigating the stringent requirements of regulatory bodies worldwide, including the Therapeutic Goods Administration (TGA) in Australia. Their expertise covers the entire lifecycle of medical devices, from initial development and Quality Management System (QMS) implementation to achieving compliance with international standards such as ISO 13485:2016 and ISO 27001:2022. They are adept at preparing technical documentation, managing risk, and ensuring devices meet the necessary criteria for market entry. SGB Consulting Services provides tailored support for Software as a Medical Device (SaMD) and helps clients achieve compliance in key markets including the UK, EU, and USA. They also offer guidance on post-Brexit solutions and UDI/EUDAMED compliance, ensuring businesses can successfully bring their innovative healthcare technologies to global consumers.
About
**Who they are**
SGB Consulting Services (Australia Market Access) is a regulatory affairs and quality assurance consultancy specializing in global market access for medical devices and IVDs. They focus on navigating complex regulatory landscapes, including TGA Australia compliance.
**Expertise & scope**
* Expertise in TGA Australia compliance, including understanding the Therapeutic Goods Administration's role in ensuring safety, quality, and effectiveness.
* Guidance on key steps for Australian market access, such as medical device classification (Classes I-IV) and conformity assessment processes.
* Support for Australian Register of Therapeutic Goods (ARTG) listing, confirming regulatory compliance for supply in Australia.
* Services encompass Quality Management System (QMS) development, Technical File creation, and Risk Management Documentation.
* Specialization in MDR and IVDR transitions, ISO 27001:2022, ISO 13485:2016, and Software Quality Assurance.
* Market access support extends to the United Kingdom, Europe, United States, Canada, Asia, Australia, and the Middle East.
**Reputation / proof points**
* Over twenty-three years of experience in the Medical Devices & IVD sectors.
* Accredited as an Internationally Certified Principal Auditor.
* Successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
SGB Consulting Services (Australia Market Access) is a regulatory affairs and quality assurance consultancy specializing in global market access for medical devices and IVDs. They focus on navigating complex regulatory landscapes, including TGA Australia compliance.
**Expertise & scope**
* Expertise in TGA Australia compliance, including understanding the Therapeutic Goods Administration's role in ensuring safety, quality, and effectiveness.
* Guidance on key steps for Australian market access, such as medical device classification (Classes I-IV) and conformity assessment processes.
* Support for Australian Register of Therapeutic Goods (ARTG) listing, confirming regulatory compliance for supply in Australia.
* Services encompass Quality Management System (QMS) development, Technical File creation, and Risk Management Documentation.
* Specialization in MDR and IVDR transitions, ISO 27001:2022, ISO 13485:2016, and Software Quality Assurance.
* Market access support extends to the United Kingdom, Europe, United States, Canada, Asia, Australia, and the Middle East.
**Reputation / proof points**
* Over twenty-three years of experience in the Medical Devices & IVD sectors.
* Accredited as an Internationally Certified Principal Auditor.
* Successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
Additional information
SGB Consulting Services assists clients in understanding the critical steps for gaining Australian market access. This includes accurately classifying medical devices according to the TGA's risk-based categories and demonstrating compliance through the required conformity assessment procedures. Their support extends to the final ARTG listing, which is essential for legally supplying medical devices within Australia. They also offer solutions for post-Brexit regulatory challenges and UDI compliance.
Key Highlights
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Specializes in TGA Australia market access for medical devices and IVDs.
Source
“Accessing the Australian market for medical devices requires compliance with the regulatory requirements set forth by the Therapeutic Goods Administration (TGA).”
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Offers support for ARTG listing, confirming regulatory compliance for Australian supply.
Source
“The ARTG listing confirms that the medical device meets the necessary regulatory requirements and can be legally supplied in Australia.”
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Provides expertise in global market access, including UK, Europe, US, Canada, Asia, and Middle East.
Source
“Market Access United Kingdom Europe United States Canada Asia Australia Middle East”
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Over twenty-three years of experience in Medical Devices & IVD sectors.
Source
“I'm a global Quality Assurance and Regulatory Affairs specialist with over twenty three years’ experience in the Medical Devices & IVD sectors.”
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Successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
Source
“I have successfully guided over 500 clients to ISO, FDA, Canadian and CE compliance with the development and improvement of Quality Management Systems (QMS) and Technical Files.”
Certifications & Trust Signals
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Accredited as an Internationally Certified Principal Auditor.
Source
“Accredited as an Internationally Certified Principal Auditor, I have been instrumental in Quality Assurance and Regulatory Affairs strategy for large medical device / IVD manufacturers.”
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Expertise includes ISO 13485:2016 registration and CE marking processes.
Source
“we are a professional quality and regulatory affairs consultancy, representing Medical Device businesses and products through the ISO 13485:2016 registration of CE marking, complaint handling and adverse incident report processes.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking TGA Australia market access
- Companies needing support with regulatory affairs and quality assurance
- Businesses navigating complex regulations like MDR and IVDR
How engagement typically works
- Consultative approach to regulatory challenges
- Focus on practical implementation of compliance requirements
Typical deliverables
- TGA compliance strategy and guidance
- ARTG listing support
- Conformity assessment documentation
- QMS and Technical File development
- MDR/IVDR transition support
Good to know
- Best when requiring specialized knowledge of Australian medical device regulations
HQ:
Bristol, United Kingdom
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, Dental
Portfolio:
6-25
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Starting from:
AUD 6,000
Included services:
Sponsor address and labeling review, Change notification and variation assessment, Annual ARTG charge reminders and continuity planning, TGA device classification and grouping
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Recall Vigilance Support:
No
Additional tga_sponsor_au Details
Device Classes Supported
Classes I-IV
Supports Artg
Yes
Onboarding Steps
Key steps include determining device classification, undergoing conformity assessment, and applying for ARTG listing.
Recall Vigilance Support
No
