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 quality assurance and regulatory affairs consultancy with over twenty-three years of experience in the Medical Devices & IVD sectors. They specialize in global market access and compliance.
**Expertise & scope**
* Expertise in navigating complex regulations such as MDR and IVDR transitions.
* Support for ISO 27001:2022 and ISO 13485:2016 standards.
* Services include Quality Management System (QMS) development, Technical File creation, and Risk Management Documentation for CE Marking.
* Specialized support for Software Quality Assurance and UDI Compliance Solutions.
* Assistance with Post-Brexit solutions.
* Guidance on market access to various regions including the United Kingdom, Europe, United States, Canada, Asia, Australia, and the Middle East.
* Specific focus on TGA Australia compliance, including understanding device classification, conformity assessment, and ARTG listing requirements.
**Reputation / proof points**
* Accredited as an Internationally Certified Principal Auditor.
* Successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
* Experience holding key positions as an Internationally Certified Principal and Lead Auditor.
SGB Consulting Services (Australia Market Access) is a quality assurance and regulatory affairs consultancy with over twenty-three years of experience in the Medical Devices & IVD sectors. They specialize in global market access and compliance.
**Expertise & scope**
* Expertise in navigating complex regulations such as MDR and IVDR transitions.
* Support for ISO 27001:2022 and ISO 13485:2016 standards.
* Services include Quality Management System (QMS) development, Technical File creation, and Risk Management Documentation for CE Marking.
* Specialized support for Software Quality Assurance and UDI Compliance Solutions.
* Assistance with Post-Brexit solutions.
* Guidance on market access to various regions including the United Kingdom, Europe, United States, Canada, Asia, Australia, and the Middle East.
* Specific focus on TGA Australia compliance, including understanding device classification, conformity assessment, and ARTG listing requirements.
**Reputation / proof points**
* Accredited as an Internationally Certified Principal Auditor.
* Successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
* Experience holding key positions as an Internationally Certified Principal and Lead Auditor.
Additional information
SGB Consulting Services focuses on providing comprehensive support for medical device and IVD manufacturers seeking to enter or maintain compliance within regulated markets. Their approach involves detailed analysis of regulatory frameworks, such as the TGA's requirements for Australian market access, which includes understanding device classification, conformity assessment procedures, and the critical step of ARTG listing. They also offer solutions for navigating the complexities of MDR and IVDR transitions, alongside robust support for Quality Management Systems (QMS) and technical documentation essential for CE marking. Buyers can expect a structured engagement aimed at achieving and sustaining regulatory compliance across multiple global jurisdictions.
Key Highlights
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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
“With an impeccable record, 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.”
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Specializes in TGA Australia market access, including ARTG listing.
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 MDR and IVDR transitions.
Source
“MDR Transition”
Certifications & Trust Signals
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Accredited as an Internationally Certified Principal Auditor.
Source
“Accredited as an Internationally Certified Principal Auditor”
-
Experience in key positions as an Internationally Certified Principal and Lead Auditor.
Source
“My extensive knowledge within the Regulatory Compliance and Quality Assurance profession has seen me hold key positions as an Internationally Certified Principal and Lead Auditor.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers
- Companies seeking TGA Australia market access
- Businesses navigating MDR/IVDR transitions
How engagement typically works
- Consultative approach
- Regulatory strategy development
- Compliance documentation support
Typical deliverables
- TGA compliance strategy
- ARTG listing support
- QMS development
- Technical File creation
- MDR/IVDR transition plans
Good to know
- Best when requiring specialized regulatory affairs and quality assurance expertise for global market entry, particularly in Australia.
HQ:
Bristol, United Kingdom
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
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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 (based on Australian regulatory framework)
Supports Artg
Yes
Onboarding Steps
Key steps for Australian market access include determining device classification, undergoing conformity assessment, and applying for ARTG listing.
Recall Vigilance Support
No
